Creating famlies / Créons des familles by Fertility Matters Canada

CLINICS’ SUCCESS RATES: WHAT THE NUMBERS MEAN

LE QUÉBEC RECULE SUR LE FINANCEMENT DE LA FIV

BLASTOCYSTS: GOOD NEWS FOR OLDER WOMEN

QUEBEC BACKTRACKS ON IVF FUNDING

68 FREEZING TIME WITH FERTILITY PRESERVATION

Canadian Magazine of Reproductive Health • Revue canadienne de la santé reproductive

Creating FAMILIES Créons des familles Outgoing President’s Message /

72 WHERE IS RESEARCH IN ASSISTED REPRODUCTION HEADED?

SPRING / PRINTEMPS 2015

Message de la présidente sortante ..... 6 / 7

FIV «légère», inséminations plus sécuritaires : les avancées de la décennie ...12 “Friendly” IVF, Safer Inseminations: Advances in the Last Decade ................ 15 Entrevue avec / Interview with LOUISE LAPENSÉE

Providing Fertility Preservation for Young Women with Cancer is a Team Approach ... 22 by JEFF ROBERTS, MD, FRCSC

Preimplantation Genetic Screening by DR. JEFF HAEBE ........................................ 26 Designated Donors: An Ideal Alternative for Semen Donation ......................... 30

Printing of this magazine was made possible thanks to the generosity of our Platinum sponsor Merck.

by ALFONSO P. DEL VALLE, MD, FRCS(C) and TAMER M.SAID, PhD, HCLD

Infertility Counselling in a Changing World Interview with DR. JANET TAKEFMAN .......... 34 Miracle Babies /

Bébés miracles .................................................... 38 / 39

Taking Stock of the Past Decade: The Good, The Bad and the Desirable ......... 48 Interview with DR. ART LEADER

L’impression de ce magazine a été possible grâce à la générosité de notre commanditaire Platine Merck.

Ethics and Assisted Reproduction Technologies in Canada: 2004-2014 ......... 54 by FRANÇOISE BAYLIS MD

Le Test Matris : un nouvel outil pour évaluer les chances de succès The Matris™ Test : A New Tool to Help Predict the Chances of Pregnancy ....... 58 Entrevue avec / Interview with Dr. ROGER PIERSON

The Infertility Awareness Association of Canada (IAAC)

Lab Breakthroughs of the Decade Interview with Dr. MARIE-CLAUDE LÉVEILLÉ ............... 66

L'Association canadienne de sensibilisation à l'infertilité (ACSI)

Multiple Births in Canada: Moving in the Right Direction .............................. 76

475 Dumont Ave., Suite 201 Dorval, QC • H9S 5W2

Interview with Dr. JASON MIN

514 633-4494

A Legal Overview: Highlights of the Past Decade ......................................... 79

1 800 263-2929

by SARA COHEN, LL.B.

The opinions expressed in this magazine are personal and do not necessarily relect those of Creating Families Les opinions exprimées dans ce magazine sont personnelles et ne reflètent pas nécessairement celles de Créons des familles

www.iaac.ca

SPRING/PRINTEMPS 2015 • Creating Families

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Creating FAMILIES Créons des familles PLATINUM SPONSORS IAAC EXECUTIVE DIRECTOR / EDITOR-IN-CHIEF Carolynn Dubé Carolynn@iaac.ca

EDITOR / TRANSLATOR / INTERVIEWS Véronique Robert carotexte@videotron.ca

ISIS Oakville Fertility Centre

Ferring Pharmaceuticals Merck

IVF Canada & the LIFE Program

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MUHC Reproductive Centre www.mcgillivf.com

Paula Chorney • Jason Hitkari Sherry Levitan • Sharon Mortimer Dan Nayot • Glenna Owen Antonia Wasowska

Ottawa Fertility Centre Pacific Centre for Reproductive Medicine Regional Fertility Program Shady Grove Fertility

I A A C NATIONAL BOARD OF DIRECTORS

VICE-PRESIDENT • Janet Takefman

Olive Fertility Ontario Network of Experts (ONE) in Fertility

Ovascience www.ovascience.com

PRESIDENT • Janet Fraser

ISIS Regional Fertility Centre

Mount Sinai Centre for Fertility and Reproductive Health LifeQuest Centre for Reproductive Medicine www.lifequestivf.com

ART DIRECTOR / GRAPHIC DESIGN Sheldon Kravitz sheldon.kravitz@sympatico.ca

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MESSAGE

breakthroughs of the decade, Dr. Tom Hannam details the impact of the increased used of 5-day embryos, Dr. Louise Lapensée describes how “friendly” IVF came about, Dr. Jeff Haebe demonstrates the significance of preimplantation genetic screening, while Dr. Hugh Clarke takes us to where research is headed.

Jocelyn Smith

The past decade has seen an increased awareness of the benefits of singleton pregnancies, and Dr. Jason Min shares the good news that progress has been made. Among options that might become more attractive in the future are the designated donor and preventive egg freezing. Drs. Alfonso Del Valle and Tamer Said tell us about the former – underused – option, whereas Dr. Kristi Maas outlines the advantages women may find in freezing their eggs before the clock starts ticking. This issue would not have been complete without the perspectives of an ethicist such as Françoise Baylis, experienced counsellor Janet Takefman, who has seen issues and clienteles change significantly over the past 10 years or lawyer Sara Cohen who offers an overview of the legal milestones.

Photo by Lisa Minnini

Outgoing President’s

Ever since Creating Families/Créons des familles was founded 10 years ago, this magazine published by the Infertility Awareness Association of Canada has done an extraordinary job at informing our readers on all topics related to infertility. It has also relieved the loneliness of so many through the moving accounts of infertility patients who let them know that, no, they are not the only ones facing this uphill struggle. This issue is very special. To mark the magazine’s 10th anniversary we invited top experts to tell us about the developments in their respective disciplines over the past decade. They all graciously agreed and we are so grateful to them. When you work in a particular field, as I have done in the world of infertility, you don’t always notice the advances that are made from day to day, or year to year even, until you look back over a long time period. We are honoured that both “deans” of the Canadian fertility world are sharing their wisdom with us. Dr. Art Leader casts a look on the health system that is at once lucid and compassionate, while Dr. Al Yuzpe relies on his experience to explain how success rates should be interpreted and what patients should look for in a fertility clinic. I particularly enjoy reading about the cutting edge in technology, so this issue is a treat: Dr. Jeff Roberts explains how to best preserve the fertility of young female cancer patients, scientist Marie-Claude Léveillé sums up the important

Créons des familles • SPRING/PRINTEMPS 2015

Sadly, this is my last President’s Message. Ten years is how long I have been IAAC’s President, so it is high time that someone else took over. I wish to thank former ED Beverly Hanck, who transformed IAAC from a small outfit into Canada’s largest transnational patient group, her successor Gloria Poirier who supervised a further expansion and raised IAAC’s profile in social media, former and current members of the board for their unwavering commitment, our member clinics and sponsors over the years. My heartfelt thanks go to Editor Véronique Robert and Art Director Sheldon Kravitz for their continued dedication to this magazine and, of course, to our Platinum sponsor Merck, who made possible the printing of this special issue. I know that new President Janet Fraser, Chief of Operations at AART Clinic in Halifax, will do a tremendous job, respected as she is by everyone in the fertility field. And IAAC is now in the capable hands of new ED Carolynn Dubé, a dynamic young woman who brings a valuable experience as the founder of East Coast Miracles. Carolynn joins IAAC at a challenging time, when Quebec cancels a funding program that

had made it a world leader. As the rest of Canada has been closely monitoring the Quebec situation, there is no denying that this is a serious setback for patients coast to coast. Dr. Neal Mahutte, a Montreal fertility specialist and the Canadian Fertility and Andrology Society’s current President, eloquently characterizes the negative consequences which the new Quebec law might have on access to care and the rate of multiple births in Quebec if the law is passed as tabled. I retired a year and a half ago, and I failed retirement. Not because I was bored but because I was given the opportunity to work with Dr. Roger Pierson and his new technology Matris™, another breakthrough you can read about in this special issue. I believe this technology is going to revolutionize fertility treatment. So this isn’t goodbye but …….see you later! My warmest wishes to everyone.

Jocelyn

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MESSAGE

de la présidente sortante Depuis la fondation de Créons des familles/Creating Families il y a 10 ans, ce magazine publié par l’Association canadienne de sensibilisation à l’infertilité a fait un travail extraordinaire d’information sur tous les sujets liés à l’infertilité. Il a aussi brisé la solitude de nombreuses personnes grâce aux témoignages de patients qui leur ont fait comprendre que, non, elles n’étaient pas les seules à traverser cette épreuve. Ce numéro est très spécial. Pour souligner le 10e anniversaire du magazine, nous avons invité de grands experts à relater les progrès dans leur discipline respective au cours de la dernière décennie. Ils ont tous accepté avec grâce et nous leur en sommes très reconnaissants. Lorsqu’on œuvre dans un

domaine particulier, comme c’est mon cas pour la fertilité, on ne remarque par toujours les avancées qui ont lieu au jour le jour, ni même d’une année à l’autre, jusqu’au moment où on regarde le chemin parcouru. Les deux « doyens » de la fertilité au Canada nous font l’honneur de partager leur sagesse. Le Dr Art Leader porte sur le système de santé un regard à la fois lucide et empreint de compassion, tandis que le Dr. Al Yuzpe s’appuie sur son expérience pour expliquer comment interpréter les taux de succès et ce que les patients doivent rechercher dans une clinique de fertilité. Les articles sur la technologie de pointe m’intéressent particulièrement, alors je suis gâtée par ce numéro, où le Dr Jeff Roberts décrit comment préserver au mieux la fertilité des jeunes femmes atteintes de cancer, la scientifique MarieClaude Léveillé résume les percées de la décennie, le Dr Tom Hannam explique pourquoi on transfère de plus en plus des embryons de cinq jours, la Dre Louise Lapensée nous renseigne sur la « FIV légère », le Dr Jeff Haebe démontre l’importance du dépistage génétique préimplantatoire et le Dr Hugh Clarke nous indique vers quoi s’oriente la recherche.

Friends of IAAC

Wishing you a Happy 10th Anniversary! Ontario Surrogacy Online www.ontariosurrogacy.com

Halton Integrative Women's Health Centre www.HIWHC.com

Body In Balance Acupuncture www.bodyinbalanceacupuncture.com

London Health Science Centre www.bodyinbalanceacupuncture.com

Ray Clinic www.rayclinic.ca

Christine Nightingale www.nightingalehealing.com

La dernière décennie a connu une sensibilisation croissante aux bénéfices de la grossesse unique, et le Dr Jason Min confirme que des progrès ont été accomplis. Parmi les options qui pourraient attirer davantage l’attention à l’avenir figurent le donneur connu et la vitrification préventive des ovules. Les Drs Alfonso Del Valle et Tamer Said expliquent les modalités de la première, et la Dre Kristi Maas dépeint les avantages pour certaines femmes de congeler leurs ovules avant que le tic-tac de l’horloge biologique ne se fasse entendre. Ce numéro n’aurait pas été complet sans les points de vue d’une éthicienne telle que Françoise Baylis, de la psychologue émérite Janet Takefman, qui a vu les préoccupations et clientèles changer radicalement ou de l’avocate Sara Cohen qui rappelle les faits saillants de la décennie. Il s’agit, malheureusement, de mon dernier Message de la présidente. Après 10 ans à la tête du conseil d’administration de l’ACSI, il est temps de passer le flambeau. Je veux remercier l’ancienne DG Beverly

Hanck, qui a fait de l’ACSI le premier regroupement de patients d’envergure nationale au Canada ; sa successeure Gloria Poirier, qui a poursuivi sur cette lancée et accru la présence de l’ACSI dans les médias sociaux ; les membres actuels et passés du conseil d’administration pour leur soutien indéfectible, nos cliniques membres et nos commanditaires. Je remercie de tout cœur la rédactrice Véronique Robert et le directeur artistique Sheldon Kravitz pour leur dévouement envers le magazine, et notre commanditaire Platine Merck, qui a permis l’impression de ce numéro spécial. Je sais que la nouvelle présidente Janet Fraser, directrice des opérations à la clinique AART à Halifax, fera un travail formidable, notamment à cause du respect qu’elle inspire dans le monde de la fertilité. Et l’ACSI est entre bonnes mains, puisque la nouvelle DG est Carolynn Dubé, une jeune femme dynamique qui apporte une expérience précieuse comme fondatrice d’East Coast Miracles. Carolynn se joint à l’ACSI à un moment délicat, où le Québec vient d’abolir le programme de financement qui avait fait de lui un leader mondial. Comme le reste du Canada suit de près la situation au Québec, il s’agit d’un sérieux revers pour les patients partout au pays. Le Dr Neal Mahutte, fertologue montréalais et l’actuel président de la Société canadienne de fertilité et d’andrologie, détaille les conséquences négatives que la nouvelle loi aura sur l’accès aux soins et le taux de naissances multiples au Québec si la loi est adoptée sans amendements. J’ai pris ma retraite il y a un an et demi … et c’est raté ! Non pas que je m’ennuyais, mais on m’a donné l’occasion de travailler avec le Dr Roger Pierson et sa nouvelle technologie Matris , une autre percée sur laquelle vous pouvez vous renseigner dans ce numéro spécial. Je suis convaincue que cette nouvelle technologie va révolutionner les traitements de fertilité. MD

Donc je ne vous dis pas adieu, mais plutôt au revoir ! Mes meilleurs vœux à tous et à toutes.

Jocelyn

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CLINICS’ SUCCESS RATES: WHAT THE NUMBERS MEAN As Canada’s most senior fertility specialist, Dr. Yuzpe is in a unique position to tell patients how success rates have evolved and how to interpret success rates posted by clinics.

Interview with Dr. Al Yuzpe, co-founder and co-director of the Olive Fertility Centre in Vancouver, B.-C.

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Creating Families: How have IVF clinics’ success rates evolved in Canada over the last decade? Al Yuzpe: The first point I would like to make concerning success rates is that the patients’ main source of information on clinics’ success rates is the Internet, and what they read is not always what they get. How to interpret success rates is not an easy matter. First of all, we cannot know if the data reported are true figures. Clinics are the ones submitting the information, and how do we know it is correct? Actually, we will know soon, since CARTRBORN, the Canadian Registry which collects IVF outcome information from all IVF clinics in Canada (on a voluntary basis) will soon be able to audit and verify data submitted. What also makes success rates difficult to evaluate is the fact that the person surfing the Internet doesn’t know how many patients a clinic is basing its reporting on. So if a clinic has two patients and one of them is pregnant – to use an extreme example – that’s a rate of 50%. But if it has 25,000 patients, then, obviously, the pregnancy data becomes much more robust. Creating Families: Not to mention that a clinic’s success rates might be influenced by the kind of patients it treats. Al Yuzpe: Exactly. Clinics may differ in the mix of patients they treat. Some might specialize in a clientele that has experienced a number of treatment failures elsewhere before coming to their facility. Others may see more patients over the age of 40, when treatment outcomes are lower. This is why, in the United States, one of the biggest problems is that if one clinic may

Choosing a clinic based on its success rate alone is not a good idea. Clinic-shopping should be about the care the patient is going to get, the expertise of the medical staff, how conveniently it is located, and so on. advertise a success rate 2% higher than another clinic, a patient may choose the first clinic for no other reason than that, while the clinic with the lower rate might be a better choice because it has better expertise in his or her particular condition. Choosing a clinic based on its success rate alone is not a good idea, as most clinics are good. Clinicshopping should be about the care the patient is going to get, the expertise of the medical staff, how conveniently it is located, and so on. Many things are equally or more important than just pregnancy rates. One last point I would like to make is that the live birth rate is more important than simply stating the pregnancy rate. Even when assessing pregnancy rates, does the number refer simply to a positive pregnancy test, or does it consider a clinical pregnancy which

confirms the presence of a pregnancy sac in the uterine cavity, the presence of a fetus and a heartbeat? Always remember, if a live birth is not the end result, how successful was the treatment! Creating Families: Still, pregnancy rates are up… Al Yuzpe: Yes they are, and for a number of reasons. Laboratory techniques have improved, so that we have better ways of growing embryos. We also have better ways of evaluating the quality of the embryos we transfer, thanks in part to two new technologies. One involves a method of selecting embryos which are chromosomally normal, called Comprehensive Chromosomal Screening or CCS. The second is a technique that is just catching on,

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It is likely less expensive in the end to undergo one IVF cycle with Comprehensive Chromosomal Screening and achieving a pregnancy because a good quality embryo was transferred, than undergoing three IVF cycles because the first two were not successful. known as time-lapse photography, which involves taking a photo of an embryo every 10 minutes for a period of 5 days during which the embryo is developing in the laboratory incubator. Indeed, our knowledge about a great deal of factors is improving. For example, two methods for assessing the receptivity of the endometrium for implantation have been developed. One involves new ultrasound technology and the other tests the endometrium for more than 100 of the genes involved in implantation. Testing of the endometrium for these factors may help determine a window of implantation, which may vary among women, so we can personalize the time at which we transfer embryos into the uterus. Better patient selection is another factor that has contributed to the surge in success rates. Based on a patient’s age and an assessment of her ovarian reserve with a test using the

anti-Mullerian hormone (AMH), we are better able to estimate her chances of pregnancy and, if necessary, we can suggest that she use donor eggs which may considerably increase her chances of success. It is important to note that Comprehensive Chromosomal Screening of embryos can almost eliminate the effect of age on the pregnancy rate in women up to 42. At our clinic we can achieve a pregnancy rate of close to 70% in patients up to 42 years of age thanks to CCS (as long as we are able to obtain chromosomally normal embryos). Another major benefit of CCS is that it brings the miscarriage rate of women in this age group from 30 or 35% down to 5 or 6%. This is huge, as you have to keep in mind that every miscarriage takes two or three months out of a woman’s reproductive life. Moreever, among CCS patients, we replace only a single embryo to obtain these very high success rates.

Dara Roth Edney y, MSW.RSW Assisted Fertility / Infertillity Counsellor

Individual and couple counselling Grief counselling / streess management Surrogate / donor couunselling and assessments Informational / decisioon-making support tel : 416.697.3191 dara@informedfertility.ca

Créons des familles • SPRING/PRINTEMPS 2015

@I nformFertility www .i nformedfertility.ca

The trend toward elective single embryo transfer has had a major impact since it greatly reduces the number of complications associated with multiple pregnancies. Creating Families: How much does Comprehensive Chromosomal Screening of embryos add to the cost of IVF? Al Yuzpe: It probably adds between $3,000 and $5,000 to the treatment, depending on the number of embryos being tested. But it is likely less expensive in the end to undergo one IVF cycle with CCS and achieving a pregnancy because a good quality embryo was transferred, than undergoing three IVF cycles because the first two were not successful. Creating Families: So you will not volunteer a figure on the increase of success rates over the last decades? Al Yuzpe: No, because it is too risky as one has to qualify everything. For instance, do you consider only single embryo transfers or multiple embryo transfers (more than 1 embryo transferred at a time) as well? The live birth rate has increased significantly over the decade for the “ideal” patient – that is a woman under 37 in her first IVF cycle where a single blastocyst (a 5 or 6-day old embryo) was transferred. For the entire country of Canada, in 2013, the rate was close to 50%. This figure may

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About Dr. Yuzpe

not be quite as high as when 2 embryos are transferred, but you must also add into the equation (for the single embryo group) the additional rate obtained from the first frozen embryo transfer as well. When the two single embryo

transfers are combined, the rates are virtually the same. The big difference is the significant reduction in the multiple pregnancy rate. Is that a good thing? That’s a story for another discussion.

Dr. Al Yuzpe is the co-founder and co-director of the Olive Fertility Centre in Vancouver. He has been involved in IVF for the past 33 years and in the field of infertility for the past 45 years. Dr. Yuzpe has been the recipient of numerous awards, including the Canadian Fertility and Andrology Society Award of Excellence in Reproductive Medicine, The Society of Obstetricians and Gynecologists Presidents Award “For his distinguished career in academic reproductive endocrinology and infertility and his dedication to women’s health in Canada and abroad,” and the Royal College of Physicians and Surgeons Speaker’s Award.

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FIV « légère », inséminations plus sécuritaires : les avancées de la décennie

Entrevue avec Louise Lapensée, fertologue à la Clinique OVO.

Créons des familles : Qu’est-ce qui a changé dans les protocoles de FIV depuis une dizaine d’années au Canada ? Louise Lapensée : Le changement le plus important est sans doute l’abandon progressif des agonistes de la GnRH (hormone de libération des gonadotrophines hypophysaires) au

Créons des familles • SPRING/PRINTEMPS 2015

profit des antagonistes de la GnRH. Ces deux substances sont utilisées pour empêcher l’ovulation chez la patiente – on ne veut pas que la patiente ovule avant la collecte de ses ovules. Les antagonistes de la GnRH ne sont pas plus efficaces que les agonistes de la GnRH pour freiner l’ovulation, mais ils allègent le processus : par rapport à la FIV conventionnelle, ils permettent de réduire le nombre d’injections, ils causent moins d’effets secondaires (notamment des chaleurs semblables à celles que bien des femmes ressentent à la ménopause) et ils diminuent également le risque du syndrome d’hyperstimulation ovarienne et le risque de développer un kyste avec l’effet

stimulant initial des agonistes de la GnRH. Voilà pourquoi à travers le monde, et pas seulement chez nous, l’utilisation accrue des antagonistes de la GnRH est à l’origine de la tendance vers ce qu’on appelle « la FIV légère » – « Friendly IVF » en anglais –, dont les résultats se comparent à ceux de la FIV conventionnelle. Elle est également à l’origine de la FIV dite « avec stimulation minimale », où la patiente prend pendant cinq jours des hormones (citrate de clomiphène ou létrozole) en comprimés, et reçoit des injections de gonadotrophines pour stimuler les ovaires au troisième ou quatrième jour.

La FIV naturelle est la solution idéale pour les femmes qui ne peuvent subir une stimulation ovarienne pour des raisons médicales ainsi que pour les femmes dont la réserve ovarienne est basse. La FIV conventionnelle implique, pour le protocole long, la prise d’analogues de la GnRH pendant deux semaines (avec les effets secondaires associés) suivi d’une période d’injections de stimulation avec gonadotrophines d’une durée moyenne de 12 jours. Il y a donc quatre semaines d’injections avant le prélèvement d’ovules en protocole long. La FIV en protocole court ou protocole antagoniste implique 12 jours de

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stimulation avec gonadotrophines injectables. La FIV avec stimulation minimale permet de réduire de quelques jours les injections de stimulation. Enfin, le recours aux antagonistes de la GnRH a permis la popularisation de la FIV dite « naturelle » où, contrairement à la FIV conventionnelle avec stimulation ovarienne, on ne stimule pas la patiente. Cette technique a été introduite au Canada par le Dr Jacques Kadoch, l’un des fondateurs de la clinique OVO, qui l’a importée de France. Le taux de succès de la FIV naturelle est moins élevé que celui de la FIV traditionnelle, étant donné qu’on ne prélève qu’un seul ovule. Embryon pour embryon, le taux d’implantation est le même, mais on ne peut procéder à un transfert d’embryon qu’une fois sur deux, alors qu’il y a presque toujours un transfert lors d’une FIV stimulée. Cependant, la FIV naturelle présente plusieurs avantages : la période des injections est limitée à quelques jours seulement, la ponction des ovules est plus rapide, on peut recommencer le processus dès le cycle suivant, et elle est la solution idéale pour les femmes qui ne peuvent subir une stimulation ovarienne pour des raisons médicales ainsi que pour les femmes dont la réserve ovarienne est basse. Il faut noter, toutefois, que la FIV naturelle est plus efficace chez les femmes de moins de 40 ans.

Les jumeaux et les triplés risquent de revenir en force au Québec avec la suppression du financement de la FIV.

Créons des familles : A-t-on assisté à des changements comparables pour les inséminations intra-utérines ? Louise Lapensée : L’utilisation du létrozole pour accroître le nombre de follicules a beaucoup augmenté au cours de la dernière décennie. On le préfère maintenant au citrate de clomiphène. Il a moins d’effets négatifs sur l’endomètre que le citrate de clomiphène. Le citrate de clomiphène a un effet antiœstrogénique sur l’endomètre. Les femmes qui prennent du citrate de clomiphène ont souvent un endomètre mince, ce qui peut réduire l’efficacité de cette hormone. Le létrozole n’a pas d’effet anti-oestrogénique sur l’endomètre et il n’entraîne pas de symptômes de ménopause très gênants tels que des sautes d’humeur, des chaleurs et des problèmes de vision (peu fréquents mais typiquement reliés au citrate de clomiphène) que connaissent plusieurs patientes avec le citrate de clomiphène. Avant l’implantation du Programme québécois de procréation assistée, on voyait couramment des inséminations qui se déroulaient en deux étapes : une

première étape où on stimulait les follicules avec du létrozole (ou du citrate de clomiphène) pour une durée de trois cycles. Si cette première étape n’aboutissait pas à une grossesse, on procédait ensuite à trois autres cycles où la patiente était stimulée avec des gonadotrophines. Or, ce deuxième type d’insémination, bien que plus efficace, donne lieu, dans 20 % des cas de grossesse, à des jumeaux, et à des triplés dans 5 % des cas – contre de 5 à 10 % de jumeaux pour les inséminations au létrozole, et moins de 1 % de triplés. Un des bénéfices considérables du Programme québécois, qui finance trois cycles de FIV, a été de réduire considérablement le nombre de naissances multiples attribuables aux inséminations, parce qu’on a fait beaucoup moins de cycles d’inséminations avec gonadotrophines : il était beaucoup plus sensé, sur le plan médical, de passer directement à la FIV après trois cycles de stimulation au létrozole. D’une part, parce que la FIV a un taux de succès trois fois supérieur à l’insémination, ensuite parce que le risque de naissances multiples était grandement réduit avec la politique de transfert d’un embryon

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unique, et enfin parce que cela est moins coûteux pour le système de santé en fin de compte. Une étude de l’Université Harvard montre clairement qu’un bébé conçu en passant des cycles d’inséminations au létrozole ou citrate de clomiphène directement à la FIV, en sautant l’étape des inséminations avec gonadotrophines, est moins coûteux parce que la grossesse survient plus rapidement. Créons des familles : Quelles pourraient être les conséquences de la nouvelle loi québécoise, qui prévoit de mettre fin au financement de la FIV mais de continuer à financer les inséminations ? Louise Lapensée : Si la loi est adoptée telle que déposée, c’est une catastrophe pour le Québec et un retour en arrière déplorable. Avec son Programme de procréation assistée, le Québec s’était démarqué en devenant un leader

mondial pour la réduction des naissances multiples : le taux de naissances multiples associé à la FIV était passé rapidement de 30 à 5 %, et les jumeaux et triplés attribuables aux inséminations, on n’en voyait presque plus. Ils risquent de revenir en force avec la suppression du financement de la FIV. Puisque la FIV ne sera plus couverte, les gens

voudront faire des cycles d’inséminations avec gonadotrophines. Le gouvernement se trouvera à financer la méthode de procréation assistée responsable du plus grand nombre de naissances multiples ! Il faut espérer que la loi sera amendée avant son adoption pour éviter cette perspective inquiétante.

Au sujet de la Dre Lapensée Dre Louise Lapensée est obstétricienne gynécologue à l’Hôpital Saint-Luc du Centre hospitalier de l’Université de Montréal depuis 1996. Parallèlement à ses activités de clinicienne, elle poursuit une carrière dans l’enseignement. Elle est professeure adointe de clinique au département d’obstétrique gynécologie de l’Université de Montréal depuis 1996. En 1994, Dre Lapensée a effectué une spécialisation en endocrinologie de la reproduction et infertilité au Massachusetts General Hospital, affilié à l’Université Harvard, à Boston. Elle a poursuivi une deuxième année de spécialisation en recherche fondamentale dans le domaine de la reproduction à l’Université de Montréal. Très active dans le domaine de la recherche en obstétrique gynécologie depuis 1997, elle a publié plus d’une trentaine d’articles dans des magazines spécialisés, a été co-auteure de deux chapitres de livres et rédigé une quarantaine de résumés analytiques. Ses domaines d’intérêt, outre la fécondation in vitro, sont la chirurgie laparoscopique et hystéroscopique de même que le traitement des fibromes utérins. Dre Lapensée est l’un des cinq membres fondateurs de la Clinique OVO. Elle est également la directrice médicale d’OVO Académie.

Dr. S.C. Foong / Dr. C.A. Greene Dr. J.K. Min / Dr. J.A. O'Keane Dr. N.D. Paterson / Dr. S.G. Scott Dr. B.C. Wong

We offer a full range of diagnostic and treatment programs for both male and female fertility disorders as well as for recurrent pregnancy loss. The desire to have a child is an exciting and compelling part of most peoples’ lives. Unfortunately some couples will experience difficulty in fulfilling this wish. However, there are fertility treatments available at the Regional Fertility Program (RFP) that can assist many couples in overcoming these difficulties.

The physicians and staff at the RFP have over 20 years of experience in the diagnosis and treatment of infertility problems. The in vitro fertilization program at the RFP began in 1984 and since that time over 13,000 babies have been born as a result of this treatment. Today it is one of the most successful IVF programs in Canada, with patients coming from across the country to receive treatment in Calgary. As you continue on your path to establishing your family the RFP has the experience and resources to assist you in your care.

Regional Fertility Program, Cambrian Wellness Centre, Suite 400, 2000 Veteran’s Place NW, Calgary, Alberta T3B 4N2 Telephone: (403) 284-5444, Pharmacy: (403) 284-5401, DSL: (403) 284-9410, Fax: (403) 284-9633 www.regionalfertilityprogram.ca

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“Friendly” IVF, Safer Inseminations: Advances in the Last Decade

Interview with Louise Lapensée, fertility specialist at Montreal’s OVO Clinic

Creating Families: What has changed in IVF protocols in Canada over the last 10 years? Louise Lapensée: The most important change, undoubtedly, is our gradual move away from GnRH (gonadotropin-releasing hormone) agonists in favour of GnRH antagonists. These two substances are used to

prevent the patient from ovulating – we do not want the patient to ovulate before her oocytes are retrieved. GnRH antagonists are not more effective in preventing ovulation, but they make the process easier: Compared with conventional IVF, they allow for a lower number of injections, cause fewer side effects (notably menopause-like hot flashes) and reduce risks of ovarian hyperstimulation syndrome and development of cysts. Around the world, the increased use of GnRH antagonists is behind the trend toward what is called “friendly” IVF, whose outcome is similar to that of conventional IVF. It is also behind “minimally-stimulated IVF” where the patient takes hormone (clomiphene citrate or letrozole) tablets for five days, and is then administered gonadotropin injections to

stimulate the ovaries on the third or fourth day. Conventional IVF implies, for the long protocol, taking GnRH analogs for two weeks (with associated side effects), followed by a series of stimulating injections of gonadotropins over 12 days on average. The long protocol thus requires four weeks of injections prior to the egg retrieval. The short-protocol IVF, also called antagonist protocol, implies 12 days of stimulation with injectable gonadotropins. Minimallystimulated IVF reduces the number of days when the patient receives injections.

The increased use of GnRH antagonists is behind the trend toward what is called “friendly” IVF, whose outcome is similar to that of conventional IVF. Finally, GnRH antagonists have made more readily available “natural” IVF where, unlike conventional IVF cycles with ovarian stimulation, the patient is not stimulated. This technique was imported into Canada from France by Dr. Jacques Kadoch, one the founders of the OVO clinic.

“Natural” IVF’s success rate is not as high as that of traditional IVF because only one egg is retrieved. Embryo for embryo, the implantation rate is the same, but embryo transfer is possible only every second cycle, whereas an embryo transfer takes place in almost every

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The multiple-birth rate associated with IVF had dropped quickly from 30 to 5%, and insemination-related twins and triplets had almost disappeared. They are likely to make a strong comeback with the end of IVF funding. stimulated cycle. However, natural IVF has several advantages: the injection period is only a few days long, the egg retrieval is quicker, the procedure may be repeated during the following cycle and it is the ideal solution for women who cannot undergo ovarian stimulation for medical reasons and for women with a low ovarian reserve. It should be noted that natural IVF is more successful with women under 40. Creating Families: Have there been comparable changes for intrauterine inseminations? Louise Lapensée: The use of letrozole to increase the number of follicles has greatly expanded throughout the last decade. We now prefer letrozole over clomiphene citrate. Letrozole has fewer adverse effects on the endometrium than clomiphene citrate, which has an antioestrogenic effect on the endometrium. Women who take clomiphene citrate often have a thin endometrium, and

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this may undermine the effectiveness of this hormone. Letrozole has no antioestrogenic effect on the endometrium and it does not cause the highly disagreeable menopause-like symptoms such as mood swings, hot flashes and vision problems (which are rare but typically associated with clomiphene citrate) affecting several patients taking clomiphene citrate. Before the implementation of the Quebec Assisted Reproduction Program, we commonly saw inseminations that were conducted in two stages : the first stage involved stimulating follicles with letrozole (or clomiphene citrate) over three cycles. If that first step did not lead to a pregnancy, one would go on to the second stage where the

patient was stimulated with gonadotropins. However, this second type of insemination, although more effective, produces twins in 20% of pregnancies, and triplets in 5% of pregnancies – versus between 5 and 10% twins for inseminations with letrozole and less than 1% triplets. One of the great benefits of the Quebec Assisted Reproduction Program, which funds three IVF cycles, is that it brought about a significant reduction in the number of insemination-related multiple births, because we initiated far fewer gonadotropin cycles. Indeed, it made a lot more sense medically speaking to move on directly to IVF following three cycles of stimulation with letrozole. On one hand, because IVF is three times as

25 years experience helping clients navigate the stress of infertility and its treatment, understand the implications of treatment options, and make sound choices in family building. Consultation, assessment, stress management, education, and psychotherapy. Individual and couple support. Psychologist fees are covered by most employee benefits plans.

Dr. Lisa Shatford

Registered Psychologist 25 Imperial Street Suite 310A Toronto, Ontario M5P 1B9 416.795.5183 drlisa@sympatico.ca

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successful as insemination, and on the other hand because the risk of multiple births was considerably reduced thanks to the single embryo transfer policy, and lastly because it is less costly for the health care system at the end of the day. A Harvard University study clearly shows that a baby conceived by a patient who moves on directly to IVF after letrozole or clomiphene citrate insemination cycles, bypassing the gonadotropin insemination stage, is less costly because pregnancy occurs faster. Creating Families: What could be the consequences of the new Quebec law, which plans to continue funding inseminations but not IVF? Louise Lapensée: If Bill 20 is passed as tabled it will be catastrophic and a deplorable step backward for Quebec. Thanks to its Assisted Reproduction Program, Quebec had set itself apart by becoming a world leader for

the reduction of multiple births. The multiple-birth rate associated with IVF had dropped quickly from 30 to 5%, and insemination-related twins and triplets had almost disappeared. They are likely to make a strong comeback with the end of IVF funding. As IVF will not be covered any longer, people

will want to undergo inseminations using gonadotropins. The government will then be funding the assisted reproduction method responsible for the highest number of multiple births! One can only hope that the Bill, before it is passed, will be amended so as to avoid leading to this worrying prospect.

About Dr. Lapensée

Dr. Louise Lapensée has practiced as an obstetrician-gynecologist at the Saint-Luc Hospital of the Centre hospitalier de l’Université de Montréal since 1996. Alongside her activities as a clinician, she has pursued a teaching career as Assistant Professor in the Department of Obstetrics and Gynecology of the University of Montreal since 1996. In 1994, Dr. Lapensée initiated a specialization in reproductive endocrinology and infertility at the Massachusetts General Hospital, affiliated with Harvard University in Boston. She pursued a second fellowship in basic research in the field of reproduction at the University of Montreal. She has been very active in the area of obstetrics and gynecology research since 1997. She has published over 30 articles in scientific journals, co-authored two book chapters and written forty abstracts. Besides in vitro fertilization, her areas of interest are laparoscopic and hysteroscopic surgery as well as the treatment of uterine fibroids. Dr. Lapensée was one of the five founding members of the OVO Clinic in 2003. She is also the Medical Director of the OVO Academy.

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BLASTOCYSTS: Good News for Older Women Interview with Dr. Tom Hannam, MD, FRCSC, REI, founder of the Hannam Fertility Centre in Toronto.

Creating Families: How important for fertility treatment is the ability to grow embryos until they are five or six days old – when they are called blastocysts? Tom Hannam: Very important. When IVF started with Robert Edwards and first IVF baby Louise Brown, clinicians could only dream of growing good embryos in the laboratory with any great success. Techniques for growing embryos have improved tremendously since then, with blastocyst development being the ultimate expression of our successes in the lab. It turns out there is a window of implantation that needs to be considered. That means that if an embryo is transferred into the uterus a little too early, or a little too late, it is less likely to implant. That is why it is very helpful to grow an embryo until such time that the woman’s window of implantation is ready. This is why in the laboratory we have worked increasingly to grow embryos up to day-5, closest to when implantation should occur. It is these well developed day-5 (sometimes day-6) embryos that are called blastocysts. A blastocyst is an embryo at the last stage of cellular

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differenciation prior to implantation. That means it has an outer shell of cells and an inner cell mass. The inner cells will become the baby, and the outer cells will become the placenta. A blastocyst is ready to stick to the lining of the uterus thanks to its outer cells. Unfortunately not every blastocyst will implant, because only half of blastocysts are genetically normal. Creating Families: Are there other advantages to growing embryos to day five? Tom Hannam: There are a number of them. The first is that we tend to get higher success rates with blastocysts than with day-3 embryos. At our clinic, for women under 35 who are willing to transfer two blastocysts, there is a 72% ongoing pregnancy rate. This high rate can be explained by the fact that we have identified the high-quality embryos. If a woman is older than 35, then we may be increasingly worried about genetic abnormalities in the embryo. Another advantage to blastocysts is that we can do genetic testing of these embryos: PGS – preimplantation genetic screening

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A major consequence of knowing that an embryo is good is that the 70% pregnancy rate is no longer just for women under 35: It’s for anybody. So women who are 38, 40 or 42, suddenly they too may be able to have that very high chance of success. aimed at finding out if the embryo has the right number of chromosomes. Creating Families: Is is possible to conduct genetic testing on day-3 embryos?

Tom Hannam: We have seeen great advances in laboratory technologies over the past 10 years, with the pace of change only increasing. Our practice is very different now from techniques we used as recently as two years ago.

Tom Hannam: Yes it is possible and sometimes preferable. However day-3 embryo biopsies can be somewhat controversial as some evidence suggests that this limits some ongoing growth. With day-5 embryos, what you biopsy is the outer cells while leaving the inner mass alone. So you’re taking some of the placenta without actually touching the embryo. We are learning many things about the best way to do genetic screening, and the better these tests get, the better we can tell a couple that this blastocyst really is a healthy embryo. You don’t have to hope for a 50-50 chance that it’s going to be OK – you can confirm that it is. A major consequence of knowing that an embryo is good is that the 70% pregnancy rate is no longer just for women under 35: It’s for anybody. So women who are 38, 40 or 42, suddenly they too may be able to have that very high chance of success. Creating Families: When did the technology become sophisticated enough so that the use of blastocysts became generalized?

Creating Families: If the chances of implantation are higher with day-5 embryos, how come implanting day-3 embryos is still fairly common? Tom Hannam: One of the advantages of implanting day-3 embryos is that it makes things simpler on the laboratory side, so some labs may prefer to implant day-3 embryos and confidently offer stable success rates. Also, it might be less expensive for patients because they don’t need the additional steps in the laboratory.

Creating Families: What does the future holds? Are we going to see 10-day blastocysts one day? Tom Hannam: We are not planning to grow embryos beyond five or six days because these are the blastocysts ready to implant. But there are three exciting developments happening. The first is: The method used to monitor embryo development from day 1 to day 5 is changing. Currently we need to remove the embryos from the incubator, look at them for a few seconds and put them back in, which doesn’t do them any favour in spite of all the precautions we take. With the advances of “time-lapse monitoring” we have them monitored by video the entire time, so we are more likely to define algorithms that will help us identify the best embryos from the beginning. If we get really good at this, we’ll be able to tell which embryo is most likely to result in a pregnancy. This is happening right now. The next development is something called “Next Generation Sequencing”. We hope this will become available in the next 6 to 12 months. It is a type of Preimplantation Genetic Screening where we look not only at the number of chromosomes but at specific genes. Again, we will be generating a tremendous amount of data. With Next Generation Sequencing we will increasingly be able to tell the prospective

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With Next Generation Sequencing we will increasingly be able to tell the prospective parents not only that they have an embryo, not only that they have a blastocyst, but that they have a blastocyst consistent with an ongoing, healthy pregnancy. parents not only that they have an embryo, not only that they have a blastocyst, but that they have a blastocyst consistent with an ongoing, healthy pregnancy – which will allow us to transfer just one embryo.

expectation is that, not only will we have higher pregnancy rates, but also higher chances of singleton pregnancies – which is of course the goal for all of us. It’s the right thing to do for everyone, most of all for the babies born from this process.

The third development has to do with The implications of these developments that window of implantation, which are huge, namely for older women. may vary from woman to woman. Embryo quality is normally a concern Techniques are being developed that for women over 38 years old. For them allow us to analyse the lining of the to try to get pregnant naturally is to risk woman’s uterus during the cycle before losing that pregnancy because it was the you perform an embryo transfer. The wrong embryo. That is emotionally idea is to find a “personalized” window extremely painful. It also takes a huge of implantation in order to optimize the timing of the transfer: you know the amount of time, because you have to let some time go by before you can get blastocyst is ready to go, and you find pregnant again. So a woman can watch out when the mother’s body is ready her fertility disappearing even if she also. So between the algorithms to find the best embryo, Next Generation becomes pregnant regularly. These Sequencing and the personalized three developments address all of that. 1 2015-02-18 4:24 PM window of implantation, the It allows the woman to immediately

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erica@healthcounsellingtoronto.com www.ericaberman.ca

Miscarriage Infertility Trauma Anxiety Depression Weight Loss Couples Counselling

identify if her embryos are healthy, and if they are not she doesn’t have to go through a loss. There will always be new things to uncover when it comes to fertility. But there is no doubt that these recent innovations will make a huge difference. It is a very exciting time in our field. About Dr. Hannam After obtaining his MD from the University of British Columbia in 1995, Dr. Hannam completed his training (FRCSC) in Obstetrics and Gynaecology at McMaster University, followed by a two-year fellowship in Reproductive Endocrinology and Infertility at the University of Toronto. Dr. Hannam has sat on the board of the Canadian Fertility and Andrology Society, and is a member of the American Society for Reproductive Medicine, the Society of Obstetrics and Gynaecology of Canada, and the European Society for Human Reproduction and Endocrinology. He has presented his research findings on numerous occasions to international peer-reviewed meetings, and is a frequent guest expert on TV and radio. Dr. Hannam founded the Hannam Fertility Centre in 2006.

647 271 6364

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by Jeff Roberts, MD, FRCSC, co-director of the Pacific Centre for Reproductive Medicine

Providing Fertility Preservation for Young Women with Cancer is a Team Approach One of the greatest challenges faced by fertility specialists is the young woman with cancer. These patients are ill-prepared for the diagnosis of cancer and the reality of their own mortality. Modern cancer treatments have become increasingly effective for cure, but unfortunately associated with significant reductions in future fertility. With a limited understanding of assisted reproductive technologies or even basic fertility issues, patients are unlikely to seek advice on fertility preservation (FP). In terms of breast cancer, younger patients are also confronted with more aggressive tumor grades and reduced disease-free survival, however, with

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ever-increasing survival, the need for adequate fertility counseling has never been greater. A multidisciplinary team is needed with a patient-centered approach to determine a realistic likelihood of success given all the factors at play. Several algorithms have been developed to help link counselors, medical oncologists, reproductive endocrinologists and psychologists on these cases. Early involvement of the fertility specialist is key to accommodate a patient’s wish for FP and to minimize delays. There are a number of reproductive treatment strategies that can be implemented to

initiate FP treatments as quickly as possible, so early collaboration between oncology and reproduction medicine teams is critical. A woman’s ovarian reserve (pool of eggs) and her individual reproductive potential declines with age, as reflected in diminishing natural pregnancy rates and success with the various fertility treatments. The chemotherapeutic agents used to combat cancer simply accelerate this steady depletion of eggs. Toxicity of chemotherapeutic treatments vary according to the specific agents used, doses, protocol, and reproductive potential of the patient at the

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time of treatment. Protocols are classified into low, intermediate, or high risk of inducing ovarian failure, with the incidence of premature menopause ranging from less than 20% to over 80%.

sperm. Whilst investigational, ovarian tissue cryopreservation serves as the most hopeful option for children and young adolescents who are otherwise limited by their reproductive immaturity.

Quantifying the toxic effects of each chemotherapeutic regimen on the woman’s reproductive function is difficult and poorly studied. Menopause occurs when the number of eggs drops below a level that renders the woman sterile, so simply measuring this risk will underestimate the impact on fertility. As expected, the incidence of acute ovarian failure, infertility and early menopause in chemotherapy patients correlates with age. Regardless of the type of chemotherapy administered, at least a fraction of ovarian reserve will be lost even if this is not immediately apparent with clinical and laboratory evaluation. Even if a patient is deemed to be at “low risk” for premature menopause, a shorter reproductive life can be expected even if regular menstrual cycles resume. Overall, the most commonly used combination chemotherapies likely advance a woman’s reproductive age by 10 years, with the onset of menopause dependent on the patient’s ovarian reserve at the start of treatment.

Early involvement of the fertility specialist is key to accommodate a patient’s wish for fertility presentation and to minimize delays.

The decision to proceed with fertility preservation treatments should take into account the patient’s age, diagnosis, oncology treatment, fertility status, and personal/social situation. Assisted reproductive technologies are the principle fertility treatments now used worldwide to generate oocytes and embryos for cryopreservation (freezing) and future use. Oocyte freezing is proving to be an excellent option for women even when a partner is present as it provides the patient with reproductive autonomy. Creation of embryos requires sperm from a partner, or when there is no partner, the use of donor

The mainstay of fertility preservation technology is the freezing of eggs and embryos generated through the administration of follicle stimulating hormone (fertility injections) and the process of in vitro fertilization. It is important to minimize any delay of cancer treatments, and to generate the maximal number of eggs without causing undue discomfort for the patient or a serious complication associated with IVF called ovarian hyperstimulation syndrome (OHSS). IVF protocols are principally defined by the methods used to prevent natural ovulation of eggs

generated during ovarian stimulation with follicle stimulating hormone (fertility injections) before they are removed with the egg retrieval procedure. GnRH antagonist protocols provide the most flexibility for ovarian stimulation. GnRH antagonist treatments are shorter, require less gonadotropin, and can virtually eliminate the risk of OHSS when combined with a newer method of preparing the eggs for retrieval called an “agonist trigger”. Ovarian stimulation can be initiated with a natural period, or through interruption of the menstrual cycle with the administration of a GnRH antagonist shortly following ovulation, or randomly throughout the patient’s menstrual cycle. One fear with ovarian stimulation in these patients is the production of high levels of estrogen, which is the principle hormonal byproduct of egg development, and of particular concern in estrogen-responsive cancers like breast. Letrozole is a potent inhibitor of estrogen production that is used as an adjuvant after chemotherapy for the treatment of breast cancer, and coincidentally also for the induction of egg production in women with ovulatory disorders. A special medication protocol (concurrent use of aromatase inhibitors and gonadotropins) can be administered to maximize embryo yield while minimizing estrogen levels in the blood stream. Since the first experiments with ovarian transplantation in animals, steady advances have been made in humans. A patient receiving chemotherapy or radiotherapy that targets the ovary can be considered a candidate for ovarian tissue cryopreservation, particularly if she is undergoing abdominal surgery. Commonly in the pediatric cancers, patients do not have enough time between diagnosis and cancer treatment to allow for an IVF cycle, which

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typically requires a minimum of 3-4 weeks. At an appropriate time after completion of the patient’s cancer therapy, the tissue is thawed and transplanted either orthotopically (back to the ovarian site) or heterotopically (another area of the pelvis or under the skin). The major barrier for this technology is survival of the transplant. With less than 50 live births from transplanted ovarian tissue and the potential for reseeding of metastatic disease, and surgical risks inherent in undergoing two surgical procedures, ovarian transplantation should still be considered investigational and should possibly be limited to

Regardless of the type of chemotherapy administered, at least a fraction of ovarian reserve will be lost even if this is not immediately apparent with clinical and laboratory evaluation. cases where surgical removal of one or both ovaries is planned. The procedure is further limited by the small number of individuals and facilities with expertise in this technique. Recent strides in cryopreservation technologies are proving to be effective fertility preservation options for Canadians, particularly through Assisted Reproductive Technology. A multidisciplinary approach to the care of these patients, and the education of oncology professionals and patients on issues related to reproduction will help ensure that cancer 24

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A multidisciplinary approach and the education of oncology professionals and patients on issues related to reproduction will help ensure that cancer patients receive appropriate fertility preservation

aromatase inhibitor/FSH stimulation. Reproductive Biomedicine Online 2010; 20(6): 7838. 16. Ives A, Saunders C, Bulsara M, Semmens J. Pregnancy after breast cancer: population based study. BMJ 2007; 334(7586): 194. 17. Morris SN, Ryley D. Fertility preservation: nonsurgical and surgical options. Seminars in Reproductive Medicine 2011; 29(2): 147-54.

counselling and services in a timely manner. patients receive appropriate fertility preservation counselling and services in a timely manner. There is no more important issue in our field of medicine. Bibliography 1.Wallace WH, Kelsey TW. Human ovarian reserve from conception to the menopause. PloS One 2010; 5(1): e8772. 2. Meirow D, Lewis H, Nugent D, Epstein M. Subclinical depletion of primordial follicular reserve in mice treated with cyclophosphamide: clinical importance and proposed accurate investigative tool. Human Reproduction 1999; 14(7): 1903-7. 3. Walshe JM, Denduluri N, Swain SM. Amenorrhea in premenopausal women after adjuvant chemotherapy for breast cancer. Journal of Clinical Ooncology 2006; 24(36): 5769-79. 4. Loren AW, Mangu PB, Nohr Beck L, Brennan L, Oktay K et al. Fertility preservation for patients with cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. Journal of Clinical Oncology 2013; 31(19): 2500-10.

Castiglione-Gertsch M, Goldhirsch A, Winer E. Age of menopause among women who remain premenopausal following treatment for early breast cancer: long-term results from International Breast Cancer Study Group Trials V and VI. European Journal of Cancer 2007; 43(11): 1646-53. 9. Larsen EC, Muller J, Schmiegelow K, Rechnitzer C, Andersen AN. Reduced ovarian function in long-term survivors of radiation- and chemotherapy-treated childhood cancer. The Journal of Clinical Endocrinology and Metabolism 2003; 88(11): 5307-14. 10. Larsen EC, Muller J, Rechnitzer C, Schmiegelow K, Andersen AN. Diminished ovarian reserve in female childhood cancer survivors with regular menstrual cycles and basal FSH <10 IU/l. Human Reproduction 2003; 18(2): 417-22. 11. Thomas-Teinturier C, El Fayech C, Oberlin O, et al. Age at menopause and its influencing factors in a cohort of survivors of childhood cancer: earlier but rarely premature. Human Reproduction 2013; 28(2): 488-95.

5. Roberts JE, Oktay K. Fertility Preservation: A comprehensive approach to the young woman with cancer. Journal of the National Cancer Institute Monographs 2005; 32: 57-59

12. Barton SE, Najita JS, Ginsburg ES, et al. Infertility, infertility treatment, and achievement of pregnancy in female survivors of childhood cancer: a report from the Childhood Cancer Survivor Study cohort. Lancet Oncology 2013; 14(9): 873-81.

6. Hickey M, Peate M, Saunders CM, Friedlander M. Breast cancer in young women and its impact on reproductive function. Human Reproduction Update 2009; 15(3): 323-39.

13. Meirow D, Biederman H, Anderson RA, Wallace WH. Toxicity of chemotherapy and radiation on female reproduction. Clinical Obstetrics and Gynecology 2010; 53(4): 727-39.

7. Letourneau JM, Ebbel EE, Katz PP, et al. Acute ovarian failure underestimates age-specific reproductive impairment for young women undergoing chemotherapy for cancer. Cancer 2012; 118(7): 1933-9.

14. Cakmak H, Rosen MP. Ovarian stimulation in cancer patients. Fertility and Sterility 2013; 99(6): 1476-84.

8. Partridge A, Gelber S, Gelber RD,

15. Oktay K, Turkcuoglu I, Rodriguez-Wallberg KA. GnRH agonist trigger for women with breast cancer undergoing fertility preservation by

18. Ronn R, Holzer HE. Oncofertility in Canada: an overview of Canadian practice and suggested action plan. Current Oncology 2013; 20(5): e465-74.

About the Author Dr. Roberts completed his residency in Obstetrics and Gynecology at McGill University, then a fellowship in Reproductive Endocrinology and Infertility at the Center for Reproductive Medicine and Infertility at Weill Cornell Medical College of Cornell University. Upon completing his training, Dr. Roberts was appointed Assistant Professor in Obstetrics and Gynecology at Brown University, where he served as a Reproductive Endocrinologist and director of the Women and Infants Hospital of Rhode Island Egg Donation Program. Presently he is the codirector of the Pacific Centre for Reproductive Medicine (PCRM) and Assistant Clinical Professor in the University of British Columbia Faculty of Medicine departments of Anesthesia, Pharmacology and Therapeutics, and Obstetrics and Gynecology. He has served on the board of executives for the Canadian Fertility and Andrology Society (CFAS) since 2008 as the National Continuing Professional Development (CPD) Director, and presently sits on the Canadian Standards Association (CSA) Technical Subcommittee on Reproductive Tissues. Dr. Roberts is particularly dedicated to the advancement of the field of fertility preservation for young women with cancer. Through his work as the director of the PCRM Fertility Preservation Foundation and the chair of the CFAS Fertility Preservation Special Interest Group, he has contributed widely to this important topic within the discipline, through lecturing, research and publication. He authored the first Canadian Clinical Practice Guideline for Fertility Preservation (2014).

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Preimplantation Genetic Screening by Dr. Jeff Haebe, Reproductive Endocrinologist and ultrasound specialist at the Ottawa Fertility Centre

The genetic make-up of all living things is very consistent within each species. Humans have a very specific genetic structure that is made up of 23 pairs of chromosomes, for a total of 46 chromosomes. A chromosome is a large strand of DNA that may have anywhere from 200 to 4500 genes coded within it. Preimplantation genetic screening is a technique associated with IVF that allows assessment of the chromosomes within embryos. This is different from Preimplantation Genetic Diagnosis which is a technique where single gene disorders are detected and diagnosed in

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embryos before they are transferred back into the potential mother. Chromosome assessment of embryos through preimplantation genetic screening techniques is a process whereby embryos are tested for the number and completeness of each chromosome pair. This is a very powerful technique that identifies chromosomally normal (euploid) embryos and chromosomally abnormal (aneuploid) embryos. Embryos revealing too much or too little chromosomal material (aneuploidy) are believed to have a high rate of

developmental arrest, implantation failure, and higher rates of miscarriage. Aneuploidy is known to be the leading genetic cause of miscarriages. Therefore, if these aneuploid embryos could be identified before they are transferred back into the uterus of the potential mother, pregnancy rates may be increased, and miscarriage rates may be decreased. Indeed, recent IVF studies have shown higher implantation rates and higher pregnancy rates with transfer of euploid embryos versus transfer of embryos which have not been screened for chromosomal abnormalities. At present, published data is still relatively small and large scale studies are required to verify these early results. However, chromosomal testing may prove to be a useful tool in treating couples with recurrent pregnancy loss, and couples suffering from multiple failed IVF cycles relating to recurrent implantation failure. Furthermore, chromosomal

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testing may be helpful in screening embryos in couples at higher risk of Downs’s syndrome and other chromosomally mediated diseases in offspring. Overall, human embryos are known to have a high rate of chromosomal abnormalities even if they appear normal under microscopic examination. Approximately 30 to 50% of normal appearing embryos are chromosomally abnormal when tested. This percentage of chromosomally abnormal embryos increases as women age. Modern day chromosome testing refers to the process as Comprehensive Chromosome Screening (CCS). There are several techniques that allow CCS, however, the most commonly used technique is called Comparative Genomic Hybridization (CGH). Unfortunately, to test for these chromosome abnormalities a biopsy of the embryo’s cells is required. Embryonic biopsy is typically performed through a process called blastomere biopsy. This technique is initiated using much the same procedure as any IVF cycle. Eggs are fertilised using Intracytoplasmic

Chromosomal testing may prove to be a useful tool in treating couples with recurrent pregnancy loss, and couples suffering from multiple failed IVF cycles relating to recurrent implantation failure.

Sperm Injection and the resulting embryos are cultured in the standard way. On culture day 3 a small hole is produced in the outer covering of the embryo using a microscopic laser. Care

is taken not to damage the embryo. The embryo continues to grow and the cells continue to divide. On culture day 5 some cells will push through the hole that was created with the microscopic laser. These extruded cells are then removed from the embryo with gentle manipulation and further use of the microscopic laser. The separated cells are then isolated and sent for chromosome testing (CCS using CGH). The biopsied embryo is typically cryopreserved later the same day. The CCS testing typically takes several days and this information will not be available soon enough to allow a fresh embryo transfer to be performed. When the results of the CCS are available, chromosomally normal embryos are selected for embryo transfer using a standard frozen embryo transfer technique. The frozen embryo transfer can take place whenever the couple is ready to attempt pregnancy. Comprehensive Chromosomal Screening techniques hold the promise of improving the efficiency of IVF by allowing the transfer of only

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Comprehensive Chromosomal Screening techniques hold the promise of improving the efficiency of IVF by allowing the transfer of only chromosomally normal embryos. chromosomally normal embryos. These chromosomally normal embryos have the best chance of creating a healthy pregnancy that will result in the birth of healthy offspring. However, to truly determine if CCS will deliver on this promise of better outcomes for couples undergoing IVF, further large-scale randomized studies will be required. Questions about the safety of

blastomere biopsy, and the accuracy of the results of Comparative Genomic Hybridization will need to be determined before physicians can advocate for the widespread use of this technology. For now, this is an exciting new technology that may improve the live birth rate of chromosomally normal offspring for infertility patients who previously had a very poor prognosis.

About the Author Dr. Haebe is an Assistant Professor at the University of Ottawa Faculty of Medicine. He has been in practice for 14 years as a Reproductive Endocrinologist in the Division of Reproductive Medicine of the Ottawa Hospital, University of Ottawa. Dr. Haebe serves as the quality advisor and Director for the Ottawa Fertility Ultrasound Unit. In 1999 Dr. Haebe completed his specialty training in Obstetrics and Gynecology at the University of Manitoba. He then underwent a fellowship at University of Western Ontario in Gynecologic Reproductive Endocrinology and Infertility. He was a founding partner of the Ottawa Fertility Centre. Dr. Haebe’s main academic focuses are on clinical IVF and Reproductive Ultrasonography.

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Centre de la Reproduction

Reproductive Centre

Designated Donors: An Ideal Alternative for Semen Donation

by Alfonso P. Del Valle, MD, FRCS(C) and Tamer M. Said, PhD, HCLD, ReproMed – The Toronto Institute for Reproductive Medicine

The use of donated semen is widely used in association with assisted reproductive techniques. Regulations and best practice policies are in place to ensure the safety and quality of the donated semen. Potential recipients have the option of choosing a specific profile from donor lists, often referred to as Donor Catalogues. Currently, the altruistic recruitment model in Canada is marred by several challenges, which have led to a shortage in semen donor samples.1 Subsequently, the importation of donor samples has been touted as an acceptable alternative. Canadian and Imported Donor Catalogues are comprised of two categories: open identity and anonymous donors. Open identity donors provide consent allowing the release of

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their identity information when requested by a donor offspring who is 18 years of age or older. On the other hand, anonymous donors have not provided such consent and thus, identity release cannot be ensured. Despite the presence of these various alternatives, often recipients are still not able find a donor profile that meets their expectations. Many recipients prefer to have and to offer their children the opportunity for a relationship with the donor. Recipients may be also be keen on continuing the genetic lineage of their partner by choosing a member of his/her family. Finally, it is not uncommon that a donor of a certain ethnicity is needed, but is unavailable through the Donor Catalogues. The

aforementioned requirements cannot be fulfilled by either open identity or anonymous donors. Therefore, there is a need for a third category of semen donors that will have the potential of addressing these requirements.

Designated Semen Donations Designated (directed or known) Donation refers to the provision of donated semen for the reproductive use of one specific recipient, who is not an intimate partner. The Designated Donor is selected and nominated by the recipient. Depending on the case particulars, the recipient may be well informed about the donor’s background, physical attributes, personality traits, skills and abilities, education and occupation as well as family history.

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Therefore, this option presents a unique opportunity to choose a donor profile that perfectly meets the recipient’s expectations.

recipients. Almost all fertility clinics in Canada offer access to counselling services that provide recipients and donors with valuable guidance about designated donations. During these sessions, the process is described and the different ramifications are discussed.

Indications for Designated Donations Different indications exist for considering a Designated Donor. These include: male partner infertility, single women, lesbian couple, co-parenting agreements and traditional surrogacy. It has been reported that some recipients may consider an informal approach to acquire donated semen.2 However, this places the recipient and most importantly the offspring at great risks since screening for infectious, genetic and semen quality is omitted. Moreover, consents and contractual agreements that define the role of the donor as well his responsibilities and liabilities are lacking.

Due to the length of the mandatory quarantine period, the average duration of a completed Designated Donor application is seven to eight months. Designated donations allow recipients to apply to Health Canada under the Donor Semen Special Access Program (DSSAP) for the inclusion of a donor who would otherwise be excluded. Such exclusions may include: 1) age greater than 40, 2) donors who have had same-sex relationships, and 3) extensive travel in areas affected by bovine encephalopathy. The policies and procedures used to process a Designated Donor application mimic closely those used to process open identity and anonymous donors. The following table highlights the similarities and differences between both types of applications:

The Designated Donor presents a unique opportunity to choose a donor profile that perfectly meets the recipient’s expectations.

Processing of Designated Donations Processing of Designated Donor applications is subject to a comprehensive set of regulations in Canada. Specifically, the donated semen should be processed in compliance with Canadian Regulations for Processing and Distribution of Semen for Assisted Conception (2000), Health Canada’s Directive – Technical Requirements for Therapeutic Donor Insemination (2000) and Guidance Document on the Processing and Distribution of Semen for Assisted Conception Regulations (2004). Additionally, the donated semen should comply with the Assisted Human Reproduction Act (2004), including Section 8 regulations which pertain to the donor’s consent. If a Designated Donation is not compliant with the regulations, it cannot be used in fertility clinics across Canada – this stipulation helps to ensure patient safety and healthy offspring. Each Designated Donor application consists of 3 phases: 1) eligibility determination and initial screening; 2) sample collection and 6-months quarantine; 3) repeat screening and specimen release. Independent legal and social counselling is always recommended for both donors and

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Designated donations offer unparalleled access to the donor’s personal, social, medical and familial background. Feasibility of Designated Donations The recruitment, processing, quarantine and release of Designated Donor semen samples are well standardized processes. Despite the considerable overall duration of the application, the number of actual visits required of the donor is limited (average: 2 to 6). Depending on the donor samples’ quality, a total of 10 to 15 semen vials are typically produced for each donor. These vials could be used in assisted reproduction.3 The released samples may be further stored and later used for subsequent pregnancies. In addition, surgically retrieved sperm may be accepted with an understanding that in vitro fertilization will be required. This option would allow the inclusion of donors who have had vasectomy.

regarding the duration of the process in order to avoid negative impacts on their management plan. References: 1.

2. Wykes, K.A., Fertility services for same-sex couples: policy and practice. Br J Nurs, 2012. 21(14): p. 871-5.

Del Valle, A.P., L. Bradley, and T.M. Said, Anonymous semen donor recruitment without reimbursement in Canada. Reprod Biomed Online, 2008. 17 Suppl 1: p. 15-20.

Said, T.M. and A.P. Del Valle, Recruitment of designated (known) semen donors: Review of application process, in 55th Annual meeting of the Canadian Fertility and Andrology Society. 2009: Montreal, QC.

About the Authors Dr. Alfonso Del Valle, MD, FRCS (C), has been practicing in the field of Reproductive Medicine and Infertility since 1987. He currently serves as a Staff Member at the Department of Obstetrics and Gynecology at St. Josephs’ Health Centre in Toronto and the Department of Obstetrics and Gynecology at the University of Toronto. Dr. Del Valle founded Canada’s largest sperm bank (ReproMed Ltd.) in 1990 and expanded it into a full service IVF facility with an onsite IVF laboratory in 2007. As a result of these initiatives, he possesses a unique combination of skills related to the field of reproductive medicine. He has authored numerous scientific publications and presented his data nationally and internationally. His main interests are in the area of in vitro fertilization, gamete donation, cryopreservation, as well as aspects related to male infertility. Dr. Tamer M. Said, PhD, HCLD/CC(ABB), graduated from Alexandria Medical School, Egypt, in 1994 and received his Master degree in Andrology in 1999. He completed his post-graduate training

In summary, designated donations offer unparalleled access to the donor’s personal, social, medical and familial background. Coupled with altruism, it is a feasible option that constitutes the best alternative for donated semen in many specific cases. Nevertheless, recipients should be counseled

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in Andrology at the Cleveland Clinic Foundation, in the U.S.A. where he worked from 2002 until 2006. Dr. Said holds a doctorate degree in Medical Sciences from the University of Groningen, The Netherlands. He is certified by the American Board of Bioanalysis (ABB) as a High-complexity Clinical Laboratory Director and a Clinical Consultant. Since 2006, Dr. Said has spearheaded the Andrology Laboratory and Reproductive Tissue Bank at ReproMed, Canada’s largest sperm bank. Dr. Said has been the recipient of numerous academic awards and research grants. He has published over 35 scientific papers in peer-reviewed journals and has presented more than 80 abstracts at both national and international meetings.

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Infertility Counselling in a Changing World Creating Families: How would you describe the way infertility counselling has evolved over the last decade?

Interview with Dr. Janet Takefman, Director of Psychological Services at the McGill University Health Centre (MUHC) Reproductive Centre

Janet Takefman: The most siginificant change is that infertility counselling acquired a new status exactly 10 years ago. That is because the Assisted Human Reproduction Act was passed 10 years ago – in 2004 – and one of its provisions mandated psychological counselling for all patients seeking fertility treatments. This legitimized counselling issues as important to the entire fertility treatment process. Before that, there was no Special Interest Group for counsellors at the Canadian Fertility and Andrology Society. All

10 years ago, the LGBTQ community formed less than 10% of our clientele, whereas today the proportion is around 30 - 35%. non-medical professionals, such as embryologists, nurses or counsellors were lumped together as Allied Professionals. However, once the law was passed, counsellors formed their own Special Interest Group, which is now very active, holds regular meetings and includes about 50 members. In spite of the fact that mandated counselling was overturned in 2010 with the Quebec challenge of the law before the Supreme Court, as were almost all controlled activities, many of the positive changes have remained. One of the most important was the development of the Assisted Human Reproduction Counselling Practice Guidelines, which were first published by CFAS in December 2009. These guidelines cover all psychosocial issues regarding egg donation, sperm donation, surrogacy and so on. Any

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counsellor can access these guidelines, which exist thanks to AHR Act. Creating Families: The clientele has changed as well… Janet Takefman: Indeed. What seemed out of the ordinary 10 years ago, namely surrogacy, egg donation or egg freezing, is now fairly common. Social egg freezing, for example – which refers to women freezing their own eggs for later use for reasons that are not of a medical nature – was considered experimental at the time by the American Society for Reproductive Medicine. Moreover, 10 years ago, the LGBTQ community formed less than 10% of our clientele, whereas today the proportion is around 30 - 35%. Close to the majority of donor sperm users belong to this community, and we need to be more accommodating and affirmative with respect to these patients. As counsellors we must be informed about their particular issues and take into account their special needs.

We’re always trying to catch up with technology as technology is always ahead of us. of recent scientific advances. We’re always trying to catch up with technology as technology is always ahead of us. At the McGill University Health Centre, I coordinate the Ethics Working Group, which is part of the Clinical Ethics Department. The group includes lawyers, ethicists, counsellors, social workers and patient representatives … We discuss policymaking for the Centre and hospital and its impact on society as a whole.

Creating Families: Would you say that counselling and ethics have had closer interactions in the last few years?

Creating Families: What might be a topic for discussion?

Janet Takefman: This has been a most significant development, in part because

Janet Takefman: PGD – preimplantation genetic diagnosis, which involves

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10 ALCORN AVENUE, STE. 201 TORONTO, ONTARIO M4V 3A9 PH: 416-238-2398 FX: 416-946-1621 E: shirley@familyandfertilitylaw.ca www.familyandfertilitylaw.ca

Licensed to practice in Ontario and New York State

testing an embryo for a particular genetic condition and only transferring unaffected embryos back into the uterus to prevent a person from having a devastating disease – would be a good example. ‘When is PGD indicated?’ is a question our Ethics committee has explored. There is a consensus that it would be indicated if the future human being were at risk of a terminal illness or of an illness leading to severe disability, suffering or disfigurement and therefore lead to a poor quality of life. Where we would not want PGD to take place would be for purposes that are forbidden by law, for example for family balancing or sex determination. However, there are grey areas that are not so clear as to whether PGD is warranted or not. For example, the presence of genes such as BRCA 1 and 2, which raise the risk of breast cancer, may not necessarily warrant PGD. We have to consider that this is a latedeveloping disease, its penetrance is not 100% and there are treatments available. We need to do a cost-benefit analysis and weigh the pros and cons of doing PGD not only from the perspective of the patient and the future child but also in terms of what is in the

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Thanks to a full body of evidencebased research, we now know that it is the quality of the family and not its structure that determines how well adjusted children are. best interest of our society and cultural values. For example, society would not be well-served if we carried out PGD to determine a personâ&#x20AC;&#x2122;s eye colour or height.

by LGBTQ parents. Thanks to a full body of evidence-based research, we now know that it is the quality of the family and not its structure that determines how well adjusted children are.

Another fascinating topic is the parallel often drawn between adoption and egg/sperm or embryo donation with respect to disclosing the origins of the conception to the future children. These areas of study are fairly recent, so the evidence is evolving and we often must extrapolate and base our recommendations on case studies.

Creating Families: How about the debate surrounding anonymous and open identity gamete donations?

The situation is quite different, however, with regards to children raised

Janet Takefman: This is a hot issue which has become more relevant in recent years. In addition to highly publicized court cases, we are definitely seeing a trend developing throughout the world, with several countries having prohibited anonymous donations, such as the UK and Australia. We have no

idea as to whether Canada will follow suit. The Salois Report, which was mandated to review the Quebec Assisted Reproduction Program, contained some very good recommendations, one of them being that the Quebec government fund not only anonymous sperm donors, as is the current policy, but open identity donors as well. It would seem that the Quebec government will not follow up on this recommendation based on the proposed Bill 20, and that is too bad since the more options we can provide our donor-conceived children the better they will be served in the future.

About Dr. Takefman

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Janet Takefman, Ph.D., is an Assistant Professor in both the Departments of Obstetrics and Gynecology and Psychology at McGill University and is Director of Psychological and Patient Services at the MUHC Reproductive Centre. She is a clinician, researcher and educator. She has co-authored more than 40 chapters and research articles on infertility and is the co-author of FertiQoL, the gold standard instrument measuring quality of life during infertility. She volunteers her expertise to several professional organizations including being past Chair of the

Clinique SinoC Care Innc. Creating New Life with Acupuncture 514 483 6669 4177 Decarie i Blvd. Montreal www.sin nocare.ca

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Mental Health Group of ASRM, current Chair of the Counselling Group of CFAS and Vice-President of IAAC.

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Miracle Babies Aria

who were born from fertility treatments in Canada in the last 10 years. Keely & Sophie Myles

Èvaline

Braxton

Jackson

Caliea and Kinley

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Bébés miracles

Elizabeth & Claire

nés de traitements de fertilité au Canada au cours des 10 dernières années.

Grayce

Mackenzie Connor & Riley Myles

Christopher McKinley Bailey

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Le Québec recule sur le financement de la FIV:

Entrevue avec le Dr Neal Mahutte, Directeur médical du Centre de fertilité de Montréal et président de la Société canadienne de fertilité et d’andrologie.

jette-t-on le bébé avec l’eau du bain ? Créons des familles : En novembre 2014, le ministre de la Santé du Québec, le Dr Gaétan Barrette, a déposé le projet de loi 20, qui élimine le financement de trois cycles de FIV institué en 2010, tout en maintenant le financement des inséminations. De plus, les femmes de plus de 42 ans se voient interdire la FIV. Qu’est-ce que cela signifie pour les patientes ? Neal Mahutte : C’est un énorme retour en arrière. La version du projet de loi 20 déposée en novembre dernier nous ramène à un système où les riches

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Quebec Backtracks on IVF Funding: Throwing out the baby with the bath water?

Interview with Dr. Neal Mahutte, Medical Director of the Montreal Fertility Centre and President of the Canadian Fertility and Andrology Society.

Creating Families: In November of 2014 Quebec’s Health Minister Gaétan Barrette tabled Bill 20, which withdraws the funding for three IVF cycles that had been instituted in 2010 while maintaining funding for inseminations. Moreover, women over 42 are forbidden to undergo IVF. What will this mean for patients? Neal Mahutte: It is a huge step backwards. The version of Bill 20 proposed in November would return us to a system where the rich have access to the best possible care, while those less

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auront accès aux meilleurs soins, mais pas les moins privilégiés. Il est indigne que les Québécois et les Canadiens, qui sont censés profiter d’un programme de santé universel, se retrouvent avec un système où on reconnaît l’infertilité comme une maladie pour la forme, en couvrant les tests de fertilité, sans couvrir les traitements. Pour remplacer la couverture universelle, le projet de loi 20 propose un crédit d’impôt progressif basé sur le revenu familial. Malheureusement, le crédit d’impôt proposé est pire que ce que nous avions avant 2010. Jusqu’en 2010, un crédit d’impôt de 50 % pour traitements de fertilité était accessible à tous. Avec le projet de la loi 20, les gens qui ont déjà un enfant, ou ont subi une ligature des trompes ou une vasectomie, ne seront plus admissibles. De plus, le crédit d’impôt s’appliquera à un cycle

privileged will not. It is unbecoming to Quebecers and Canadians, who are supposed to enjoy universal health care, to end up with a system that pays lip service to infertility as a health condition by paying for infertility tests, but not for treatments. Bill 20 proposes a graduated tax credit system based on family income in place of universal coverage. Sadly, the proposed tax credit is worse than what we had prior to 2010. Before 2010, a 50% tax credit for infertility treatments was available to everyone. With Bill 20 people who already have a child, have had a tubal ligation or a vasectomy will not be eligible. Furthermore, the tax credit will apply to only 1 cycle in women under age 37 and only 2 cycles in women age 37 to 42. For those whose combined family income is $120,000 the tax credit amounts to only

La version du projet de loi 20 déposée en novembre dernier nous ramène à un système où les riches auront accès aux meilleurs soins, mais pas les moins privilégiés.

seulement pour les femmes de moins de 37 ans et à deux cycles seulement pour les femmes de 37 à 42 ans. Pour ceux dont le revenu familial total est de 120 000 $, le crédit d’impôt n’est que de 20 %. Pour les couples qui gagnent en tout 50 000 $ ou moins, le crédit d’impôt est très généreux (80 %), mais c’est un mirage : si votre revenu familial est de moins de 50 000 $ par année, comment trouverez-vous 10 000 $ pour payer votre cycle ? Créons des familles: En général, les traitements de fertilité ne sont pas couverts dans le reste du Canada non plus… Neal Mahutte : C’est exact, mais l’Ontario prendra peut-être le relais maintenant que le Québec a renoncé. Le projet de loi 20 fait mal paraître le Québec aux niveaux national et

The version of Bill 20 proposed in November would return us to a system where the rich have access to the best possible care, while those less privileged will not.

20%. For those couples earning $50,000 or less the tax credit is very generous (80%) but this just a mirage. If your family income amounts to less than $50,000 per year how will you come up with $10,000 to pay for your cycle in the first place? Creating Families: Fertility treatment is not covered, by and large, in the rest of Canada either… Neal Mahutte: True, but maybe Ontario will take the lead now that Quebec has dropped the ball. Bill 20 makes Quebec look pretty bad on the national and international level. Most countries in Europe cover IVF, and even in the USA, long resistant to public funding of health care, an increasing number of States mandate IVF coverage. It is quite sad to see Quebec go from being a leader on the North

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international. La plupart des pays européens couvrent la FIV, et même aux États-Unis, traditionnellement peu portés sur le financement public des soins de santé, de plus en plus d’États ont rendu obligatoire la couverture de la FIV. Il est vraiment triste de voir le Québec passer du statut de leader sur le continent nord-américain à la queue du peloton. Créons des familles : Le financement de la FIV jumelé à une politique de transfert d’un embryon unique a réussi à réduire considérablement le nombre de naissances multiples au Québec. Que pourrait-il arriver au taux de naissances multiples sous la nouvelle loi ? Neal Mahutte : Ceci est un autre problème. Il y a très peu de grossesses multiples au Québec à l’heure actuelle. Selon la base de données

American continent to the back of the line. Creating Families: IVF funding tied to a policy of single embryo transfer succeeded in bringing down considerably the number of multiple births in Quebec. What could happen to the rate of multiples under the new legislation? Neal Mahutte: This is another

CARTR-BORN, le taux de grossesses gémellaires est de 7 % et les grossesses multiples d’ordre supérieur ont été éliminées. Cependant, couvrir les inséminations et non la FIV, comme le prévoit la nouvelle loi, est une invitation aux naissances multiples. En effet, si les premières inséminations au Clomid ou au Femara échouent, les patients voudront ensuite recourir à des médicaments plus puissants – les gonadotrophines, qui augmentent le risque de grossesse multiple – lors de leurs inséminations subséquentes. L’ironie de la chose est qu’avec la nouvelle loi le gouvernement se trouvera à financer la méthode de procréation assistée qui nous offre le moins de contrôle sur les grossesses multiples.

Neal Mahutte : Je serais très étonné qu’elle soit conservée dans la version finale de la loi. Elle a des implications éthiques et légales très sérieuses en ce qui concerne le respect de l’autonomie des patients et la discrimination. Il est vrai que le taux de succès des femmes

Il est triste de voir le Québec passer du statut de leader sur le continent nord-américain à la queue du peloton.

Créons des familles : Que pensez-vous de la clause interdisant à toute femme de plus de 42 ans de subir une FIV ?

problem. There are very few multiple pregnancies in Quebec at the moment. According to the CARTR-BORN database the twin pregnancy rate is 7% and high-order multiple pregnancies have been eliminated. However, when you cover inseminations and not IVF, as will happen under the new law, you are inviting multiples. If the first insemination cycles with Clomid or Femara do not succeed, then patients will want to use stronger medications –

It is sad to see Quebec go from being a leader on the North American continent to the back of the line. gonadotrophins, which raise the risk of multiple pregnancies – for subsequent inseminations. The irony is that with the new proposal the government will find itself funding the assisted reproduction method for which we have the least ability to control multiples.

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qui utilisent leurs propres ovules diminue avec l’âge, mais je pense que tout le monde reconnaît qu’il y a une différence considérable entre ne pas vouloir payer pour quelque chose et l’interdire complètement. Créons des familles : Et qu’en est-il pour les femmes qui ont recours aux ovules de donneuse ? Habituellement, les femmes envisagent cette option justement à partir de l’âge de 42 ans. Neal Mahutte : Ils ont totalement négligé cet aspect. Si la loi est adoptée telle que déposée, le Québec deviendrait la seule juridiction dans le monde à interdire aux femmes de plus de 42 ans de recevoir de l’aide pour devenir enceintes. Le ministre Barrette a dit publiquement qu’il voulait empêcher les femmes de se faire du tort à elles-mêmes. Passons sur l’attitude

paternaliste. On se demande sur quelles preuves il base son opinion. La différence entre les taux de morbidité et

de mortalité attribuables à la grossesse chez les femmes de 42 ans et de 43 ans doit être insignifiant.

Si la loi est adoptée telle que déposée, le Québec deviendrait la seule juridiction dans le monde à interdire aux femmes de plus de 42 ans de recevoir de l’aide pour devenir enceintes.

En fait, les risques associés à la grossesse à 43 ans sont très faibles, et pour les femmes en bonne santé ils demeurent faibles jusqu’à la fin de la quarantaine. Entre 1996 et 2011, le taux de mortalité maternelle au Canada chez les femmes de plus de 40 ans était de 0.02 %. Comparez cela avec le risque de décès à l’hôpital de 0.2 % pour les patients qui se font remplacer un genou, ou le risque de décès à l’hôpital de 0.8 % pour les patients qui se font remplacer une hanche. Si le ministre applique un seuil de taux de mortalité à 0.02 % pour tous les traitements médicaux, alors il faudrait mettre fin à bon nombre d’interventions de routine dans les hôpitaux… Cet argument ne tient simplement pas la route.

Leaving aside the paternalistic attitude, one wonders on what evidence he bases his opinion. The difference in morbidity and mortality rates due to pregnancy between women aged 42 and those aged 43 is insignificant.

Creating Families: What do you think of the provision forbidding any woman over 42 to undergo IVF? Neal Mahutte: I would be very surprised if that remained in the final legislation. It raises very serious ethical an legal implications with respect to patient autonomy and discrimination. It is true that the success rate in women using their own eggs declines with age, but I think we all recognize that there is a big difference between not wanting to pay for something and outright prohibiting it. Creating Families: What about women using donor eggs? Women usually consider that option precisely when they are 42 and older. Neal Mahutte: They totally neglected that aspect. If the law is passed as

Quebec would become the only juridiction in the world not allowing women over 42 to receive help in becoming pregnant. tabled, Quebec would become the only juridiction in the world not allowing women over 42 to receive help in becoming pregnant. Minister Barrette has said publicly that he wanted to save women from doing harm to themselves.

Actually, the risks associated with pregnancy at age 43 are quite low, and for healthy women they remain low throughout their 40s. Between 1996 and 2011, the maternal mortality rate in Canada for women over the age of 40 was 0.02%. Compare that with 0.2% risk of death in hospital for an elective knee replacements or 0.8% risk of death in hospital for patients who have elective hip replacements. If the Minister applies a 0.02% mortality rate threshold across the board to all medical treatments then much of what is routinely done in hospitals would have to be stopped… The whole argument just falls apart.

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Créons des familles : Que pourrait-il arriver aux ovules et embryons congelés que les femmes de plus de 42 ans ont entreposés ? Neal Mahutte : Peu après l’annonce de la nouvelle loi, le Dr Barrette et moi-même avons été interviewés en direct à l’émission The Current à la radio de la CBC à Montréal. On lui a demandé ce que les femmes de plus de 42 ans devraient faire avec leurs embryons congelés. Il a répondu qu’ils devraient être éliminés. On lui a fait remarquer que ces embryons sont la propriété des femmes. Il a alors semblé avoir une révélation et il a dit en substance : « Eh bien, elles devront les

Creating Families: What could happen to the frozen eggs and embryos that women over 42 have in storage? Neal Mahutte: Shortly after the new law was announced, Dr. Barrette and myself were interviewed live on The Current, on CBC Radio. He was asked what women over 42 should do with their frozen embryos. He answered that they would have to be discarded. The reporter then pointed out that these embryos are the women’s personal property. He then seemed to have an epiphany and said, “Well, then they will have to take them somewhere else.” Except that there is a provision in the law that fines physicians

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transférer ailleurs. » Sauf qu’une disposition de la loi impose une amende de 50 000 $ aux médecins qui aideront leurs patients à obtenir des traitements de fertilité à l’extérieur de la province si ces traitements sont interdits au Québec. Comment donc les patientes sont-elles censées récupérer leurs embryons ? Dans une glacière à piquenique ? Créons des familles : Comment expliquez-vous que le projet de loi 20 semble si mal conçu ?

Neal Mahutte: Le problème fondamental au Québec est que le gouvernement n’a jamais été disposé à consulter les spécialistes de la FIV. Je ne comprends pas vraiment d’où vient cette attitude, mais elle révèle un sérieux manque de confiance et un manque de respect envers notre profession. Le Collège des médecins du Québec ne considère toujours pas la médecine de la reproduction comme une spécialité à part entière. En autant que je sache, aucun spécialiste en fertilité n’a été consulté lors de la préparation du projet de loi 20. Ce n’est pas un secret que le gouvernment cherche à épargner de l’argent. Mais ils auraient pu demander aux professionnels dans ce domaine : « Nous devons réduire nos coûts. Quel est le meilleur moyen d’y parvenir ? »

$50,000 if they assist patients in accessing fertility treatment outside the province if that treatment is forbidden within the province. How exactly are patients supposed to retrieve their embryos? With an ice cooler?

Collège des médecins du Québec still does not consider reproductive medicine as a medical specialty in its own right. As far as I am aware, no fertility specialists were consulted on the drafts of Bill 20. It is no secret that the government is trying to save money. But they could have asked professionals in the field, “We have to cut our costs, what’s the best way to do that?”

Creating Families: How do you explain the fact that Bill 20 seems so ill-conceived?

Creating Families: What should they have done, in your view?

Neal Mahutte: The fundamental problem in Quebec is that the government has been unwilling to consult IVF specialists. I don’t fully understand the origins for this, but it speaks to a deep lack of trust and an overall lack of respect for our profession. The

Neal Mahutte: We know that there has to be an age cutoff for funding women doing IVF using their own eggs because the cost per baby beginning at age 40 rises dramatically. In Quebec a baby born to a woman aged 40 costs on average $43,000. At 41, the cost goes

Créons des familles : Comment auraient-ils dû procéder à votre avis ? Neal Mahutte : Nous savons qu’il doit y avoir un âge limite pour le financement de la FIV chez les femmes qui utilisent leurs propres ovules, parce que le coût par bébé augmente radicalement à partir de l’âge de 40 ans. Au Québec, un bébé né d’une femme âgée de 40 ans coûte en moyenne 43 000 $ À 41 ans, le coût grimpe à 62 000 $, puis à 79 000 $ à 42 ans et à 104 000 $ à 43 ans. Alors une chose qu’il auraient pu envisager est simplement de cesser de financer la FIV vers l’âge de 40 ans. Une autre option aurait été de ne plus financer la FIV après une ligature des trompes ou une vasectomie, en expliquant que l’individu a fait un choix conscient au moment de l’intervention et par conséquent qu’il ne peut

up to $62,000, then at 42 to $79,000 and at 43 up to $104,000. So one thing they might want to consider is simply stopping the funding for IVF around the age of 40. Another option would be remove IVF funding after tubal ligation or vasectomy on the grounds that the individual made a conscious choice at the time to have the procedure and therefore should not expect society to pay for IVF if they later change their mind. Another option would be to fund a certain number of egg retrievals rather than 3 completed cycles. The reason is that under the current funding rules, a cycle counts only if an embryo transfer occurs. As a result when patients have failed two cycles, many will only accept a high quality blastocyst for transfer

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Canadian Infertility Awareness Week Semaine Canadienne de Sensibilisation à l’Infertilité May 19 - 28, 2015 du 19 au 28 mai

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s’attendre à ce que la société paie la FIV s’il change d’avis par la suite. Ils auraient pu aussi décider de financer un certain nombre de collectes d’ovules plutôt que trois cycles complets. En vertu des règles de financement actuelles, un cycle n’est comptabilisé que s’il y a transfert d’embryon. En conséquence, après deux cycles sans succès, certains patients accepteront seulement un blastocyste d’excellente qualité pour le transfert lors du troisième cycle. Si les embryons n’atteignent pas le stade de blastocyste au jour 5, ou ne sont pas assez « beaux », ils préfèrent les éliminer et avoir ainsi la possibilité de refaire un autre cycle. Les données de CARTR indiquent qu’il n’y a pas de transfert dans 20 % des cycles de FIV au Québec en dépit du fait qu’il y a eu collecte

during the third cycle. If the embryos don’t reach the blastocyst stage by day 5, or don’t look “nice” then they would rather discard them so that they can try again. The CARTR data show a 20% rate of IVF cycles in Quebec without transfer despite the fact that an egg retrieval occurred in the vast majority of those cycles. If the government paid only for a set number of retrievals that would lower the number of IVF cycles and reduce embryo discard.

d’ovules au cours de la grande majorité de ces cycles. Si le gouvernement ne payait que pour un nombre déterminé de collectes d’ovules, cela réduirait le nombre de cycles de FIV et d’embryons éliminés. Créons des familles : Croyez-vous que le projet de loi 20 sera adopté dans sa forme actuelle ? Neal Mahutte : Je crois qu’il y a de bonnes chances qu’il soit amendé. Si nous pouvons engager un dialogue avec le ministère de la Santé, je pense que nous pouvons aider à réduire les coûts de manière significative tout en conservant les atouts fondamentaux du programme – un accès raisonnable et équitable à des soins de qualité jumelé à des taux de grossesses multiples très faibles.

Creating Families: Do you think that Bill 20 will be passed as it now stands? Neal Mahutte: I think there is a chance that amendments will be made. If we can engage in a dialogue with the Health Ministry then I think we can help them significantly reduce costs while still maintaining the fundamental strengths of the program – fair and equal access to high quality care coupled with a very low multiple pregnancy rate.

Au sujet du Dr Mahutte

Le Dr Neal Mahutte est membre du Collège royal des médecins et chirurgiens du Canada ainsi que de l’American Board of Obstetrics & Gynecology and Reproductive Endocrinology & Infertility. Après avoir obtenu son diplôme de premier cycle de l’Université Stanford, il a fait ses études de médecine et sa résidence en obstétrique-gynécologie à l’Université McGill, puis occupé un poste de chercheur en endocrinologie de la reproduction et infertilité à l’Université Yale. En 2003, il a été nommé professeur adjoint d’obstétrique et de gynécologie à la Dartmouth Medical School, aux États-Unis. En 2007, le Dr Mahutte est rentré au Canada pour devenir le Directeur médical du Centre de fertilité de Montréal, qui effectue plus de 1 000 cycles de FIV par année. Très intéressé par la recherche, il a également publié plus de 40 articles scientifiques et chapitres de livre, et il a pour objectif de dispenser à ses patients les soins de fertilité de la meilleure qualité. Le Dr Mahutte est actuellement président de la Société canadienne de fertilité et d’andrologie.

About Dr. Mahutte

Dr. Mahutte is board certified by both the Royal College of Physicians and Surgeons of Canada and the American Board of Obstetrics & Gynecology and Reproductive Endocrinology & Infertility. He did his undergraduate degree at Stanford University and then completed his medical degree and residency training in Obstetrics & Gynecology at McGill University. He did a 3-year fellowship in Reproductive Endocrinology & Infertility at Yale University. In 2003, he became an Assistant Professor of Obstetrics & Gynecology at Dartmouth Medical School in the United States. In 2007 Dr. Mahutte returned to Canada to become the Medical Director of the Montreal Fertility Centre, a center that now performs over a thousand IVF cycles per year. A strong supporter of research, he has published more than 40 scientific papers and book chapters, and he aims to provide his patients with the highest quality of fertility care. Dr. Mahutte is currently the President of the Canadian Fertility and Andrology Society.

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Taking Stock of the Past Decade: The Good, the Bad … and the Desirable A known advocate for health policies that promote the quality and safety of and access to assisted human reproduction for infertile Canadians, and one of the most respected and experienced practitioners in his field, Dr. Leader shares his thoughts on the impact of ART on the health system and what changes he would like to see in the future.

Creating Families: How would you sum up what has happened in the fertility field over the last decade? Art Leader: On the upside, we have seen the success rates of IVF increase gradually, the rates of multiple pregnancies, especially that of triplets and

higher order multiples, decrease significantly, and an increase in the use of assisted conception treatments for non-medical infertility. The safety and risks of assisted conception are better known and accepted. Cryopreservation by vitrification has made a quantum leap from innovation to clinical therapy. It has opened new doors in fertility preservation. We have seen global funding in Quebec come and then be withdrawn, Manitoba and New Brunswick have stepped forward to offer financial support while the infertile have struggled for recognition by other provincial health authorities. On the downside, we have failed to educate young Canadian adults on how to maximize their chances of fertility and to support those who would first choose family and career. The population is ageing and more women are looking to become pregnant later in life when they become financially and professionally secure. As a result, in the last decade we have seen

more people coming forward to avail themselves of various fertility treatments, at a later age. After age 35, fertility treatments can’t compensate for the age-related natural decline in fertility. To try to overcome the lower pregnancy rates, patients ask for the transfer of multiple embryos. Pregnancy at a later age is medically more complicated and more costly, particularly over the age of 40, and the burden on the health care system has increased accordingly. We have also seen, with the legal acceptance of non-heterosexual relationships, more people coming forward to build families with donor sperm, donor eggs, or in the case of male couples, both donor eggs and surrogacy. Pregnancy costs are increasing as both traditional and non-traditional couples are forced to go outside of Canada for care that is widely unavailable in Canada because there is no legal framework for anonymous surrogacy

Interview with Dr. Art Leader, Reproductive specialist and Director of Research at the Ottawa Fertility Centre

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relationships or egg donation. When Canadians come home with their multiple pregnancies conceived under poorly regulated circumstances we are left to provide care often at higher costs than singletons conceived by young women. So we have more high-risk multiple pregnancies either being generated in Canada, or outside of Canada after reproductive tourism, and then coming back. In Quebec, we have seen that the costs of the funding program increased beyond budgeted amounts, along with the number of children born, so that the health services are being stressed by greater numbers of people who are pregnant after assisted reproduction, and these people on average are older when they come for obstetric care than spontaneous pregnancies. As most of this activity is occurring without any oversight by health authorities in Canada, the health care systems are dealing with the consequences as they appear without being able to budget/predict or plan for the changes that are coming. Moreover, we know that assisted reproduction technology pregnancies are associated with slightly higher rates of birth defects that

are most likely related to the underlying infertility, and as the number of pregnancies increase, so do the complexities of neonatal and paediatric care required. So we are likely to see an increase in complex pregnancies and in children who may have more complex medical requirements. Finally, when dollars are allocated for infertility care, then obviously there are fewer dollars for other aspects of an already stressed health care system.

You need a policy that addresses access, and accepts the fact that if more people avail themselves of the services, even if they all have singletons, everything can increase.

As Canadians become more aware of their infertility, more people are requesting services, and even if you limit the number of embryos that are transferred, as we saw in Quebec, the fact that they’re treating more people means that even if the chances of twins are low with single embryo transfer, you have more people having twins. The burden on the system per patient is less but the overall burden on the system is greater. Creating Families: Could it be that many twins in Quebec are due to the large number of inseminations, which are also covered by the Quebec funding program? Art Leader: Absolutely. Although multiple births from IVF went down substantially to 7% with funding, open access to superovulation with IUI saw a 10% multiple pregnancy rate in the last year for which statistics are available. This means that you not only need a health policy that addresses IVF but also all assisted reproduction. You need a policy that addresses access, and accepts the fact that if more people avail themselves of the services, even if they all have singletons, high-risk pregnancies can still occur with singletons, so that everything can increase.

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Creating Families: One can also assume that women who freeze their eggs for later use will be of advanced reproductive age as well when they become pregnant? Art Leader: Of course. Most women who freeze their eggs plan use them when they’re older, meaning they may have the higher risks associated with being pregnant at an older age. That risk can be even higher in cancer survivors. Another thing that will change – and that is not a bad thing – is that women who resort to egg preservation will be more financially secure, will be more mature and

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It’s very good that we’re trying to reduce maternal mortality and morbidity outside of Canada but it would be nice if we put resources into our own “third world pregnant women”. will be more mature in their demands on the system for the services they require in order to raise the child, particularly day care and education services. At parent-teacher meetings of

the future not all parents will be in their thirties; more will be in their forties and fifties, so they’ll be much more discriminating customers for health services as well as education services. Thus, egg freezing will have an impact, but not immediately… The most significant development in the last 10 years is gamete vitrification, and that will allow delayed parenting with huge both societal and economic impact. Creating Families: Do you see egg freezing by women as becoming common? Art Leader: In our clinic it has increased ten-fold in the last two years. It needs to be remembered that egg freezing is not an insurance plan, but a hedge against agerelated infertility. A typical non-cancer case would be a woman coming to us and saying, “I’ve just finished my bachelor’s degree, I want to do my PhD and then a post-doc, and then I may be ready for a family.” Prior to

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vitrification this was unrealistic, because the egg survival rate was so poor. With vitrification and egg survival rates getting better, it becomes a viable alternative for women. Cancer patients or people with chronic illnesses will also benefit, and this is obviously a good thing. Transgender patients may also present a new category of consumers with their unique needs. Creating Families: What about the use of donor eggs? Art Leader: This has also phenomenally increased. And again these are older women, by and large women over 40, even up to 50, and they require much more intensive preconception workup, which is also costly. The risks in Canada – if you look at the morbidity/mortality statistics – are not what they are in the States; but the data on women over 50 who give birth in the United States, obviously with donor eggs, show that consequences of pregnancy are far more significant at that age.

Why does a woman have to adopt the child delivered by the surrogate? And if you’re in a same-sex

Older women are having cardiac arrests, heart failure, and severe hypertension to name a few, even women who are otherwise healthy, because of the physiological burden of pregnancy. The fact is that when you’re younger your blood vessels are more elastic, your whole body is more elastic and it becomes more stiff as you get older, with reduced heart, lung and kidney reserve to accommodate pregnancy’s 30% increase in blood volume, the increased pressure on the lungs from the increased uterus size and the increased body weight. Creating Families: What about the upside? Art Leader: The upside is that we are creating families and giving birth to taxpayers. Families are the core to a stable society. More people will pay taxes in the future thanks to children born from these technologies at a

time when the seniors’ population will be increasing, today’s workforce is contracting and birth rates are low. There is a short-term cost and a short-term dislocation of health care resources, but the net contribution from children born from ART is a positive one for society. Talking about birth rates, there is an illusion that birth rates are going up nationally, but this is only happening naturally among First Nations’ communities, which are high-risk pregnancies by virtue of the fact that the women tend to be young and economically disenfranchised. First Nations women do not have the same access to first class pregnancy care that other Canadians enjoy. It’s very good that we’re trying to reduce maternal mortality and morbidity outside of Canada but it would be nice if we put resources into our own “third world pregnant women”.

relationship, what you want is to encourage people in those circumstances to build a family. So why not make the law more friendly?

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We have brought safer, more effective care to a broader range of infertile Canadians.

Another positive development will be our ability to test for a multitude of genetic traits in gamete donors and embryos as well as the fetus. Genetic testing will be more widespread and we will be able to perhaps reduce or avoid the unwanted birth of children with life-ending medical conditions, although, obviously, ethical concerns are going to be huge. It will be critical for Canadian fertility clinics not only to understand the limits but to have a process to evolve in the best interest of the child. Creating Families: So what do you see is the main issue for the health care system? Art Leader: There are two broad issues for the health care system. First, how do we manage the allocation of resources for the infertile population? And if one provides such care as part of universal health care, then where do we draw the line? With the introduction of Bill 20, Quebec has pulled back from Canada’s most generous and equitable infertility care program. What replaces the previous law is a law that chooses to micromanage infertility (and medical care) and proscribes who should be treated and

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how. Quebec has shown that unregulated infertility treatments with no oversight and no regulations were not economically viable. At the same time Quebec is facing the challenge now of declining birth rates, an ageing population with low immigration rates, people who are in non-traditional relationships and people who have families from a previous relationship but want to build a new family together… Defining the boundaries of care is going to be the biggest challenge. A second challenge will be how we integrate innovations into care in such a way that safety and efficacy are preserved in the best interest of the child. The final challenge looming in the future is the larger and ever-increasing pool of frozen embryos and frozen gametes and what will be done with them. That is not so much an economic consideration as an issue of the legal framework. When is a sperm, egg or embryo abandoned? What can we do with abandoned gametes when their “owners” can’t decide? Moreover, the whole issue of

posthumous reproduction still has to be dealt with. Creating Families: You have often called for a more compassionate attitude on the part of the health care system… Art Leader: I believe one of the things that the health care system will have to think about is whether it will remain punitive, as it is now – in other words, it sees a certain set of activities as being bad or criminal. It may have to shift to try to basically promote good habits and activities that are in the best interest of society and the health care system, rather than trying to prohibit things that it considers to be bad. Yes, there needs to be a change of attitude from preventing harm to promoting good. Ontario, which has the most provincial clinics that undertake assisted reproduction, has archaic family laws and a very negative attitude, or prohibitive attitude, towards the whole process of assisted reproduction. For example, if you have a medical need for a surrogate, the question is: How can the law facilitate the fact that commissioning couples

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choose to use a surrogate, why do they have to go through the adoption process? Why does a woman have to adopt the child delivered by the surrogate? And if you’re in a same-sex relationship, what you want is to encourage people in those circumstances to build a family. So why not make the law more friendly? When it comes to adoption – it’s not assisted reproduction but it’s still family building – why not make it easier for single people or same-sex couples to adopt when the goal is to find a forever family for children? Why not try to encourage people who need surrogacy to use it instead of creating barriers and have the courts deal with the matter all the time? When it comes to posthumous reproduction or frozen embryos, what we basically say at the moment is: Those things should be decided by the lawyers. We always invoke a legal argument instead of saying: How can we make this desirable activity easier to achieve? How can we help people who are dying to achieve their dying wishes, without telling their survivors who wish to use their sperm or eggs, “You have to go to court to sort this out.” Creating Families:: In conclusion, would you say that the accomplishments in the last decade have been mostly positive? Art Leader: No doubt about it. We are able to help more people achieve pregnancies. IVF’s success rates have gone up, to the point

More people will pay taxes in the future thanks to children born from these technologies at a time when the seniors’ population will be increasing, today’s workforce is contracting and birth rates are low. that with one IVF cycle, including any frozen embryo transfer cycles, we’re probably close to a 80% clinical pregnancy rate in women under 36. I think we have reduced our barriers – we used to have very judgmental barriers as to who we would treat in terms of non-traditional families, and now we have provided access to all Canadians. We provide safer care with severe hyperstimulation and multiple pregnancy rates going down. In short, we have brought safer, more effective care to a broader range of infertile Canadians. With innovations, we need to do the right thing and to do it safely and effectively.

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About Dr. Leader

After his internship in internal medicine, Dr. Arthur Leader was appointed as a consultant in research management to the Expanded Program in Human Reproduction at the World Health Organization in Geneva. He then completed an MRC Fellowship in Obstetrics and Gynecology at the Karolinska Institute (Stockholm) and his residency in Obstetrics and Gynaecology at the London (UK) teaching hospitals. After obtaining his Canadian specialty certification in Obstetrics and Gynecology and completing further fellowship training in Reproductive Endocrinology and Infertility at the University of Calgary, he co-founded the IVF program at the Foothills Hospital in 1983. He joined the University of Ottawa in 1986 and co-founded the IVF program at the Ottawa Hospital in 1988. He moved his practice to the Ottawa Fertility Centre in 2006. Dr. Leader is a Full Professor of Obstetrics, Gynecology and Medicine (Endocrinology) at the University of Ottawa, an attending physician at the Ottawa Hospital and a consultant and founding partner of the Ottawa Fertility Centre. He is a past President of the Canadian Fertility and Andrology Society and a recipient of its Award of Excellence in 2006. Dr. Leader is the author of over 100 articles in refereed journals, several book chapters and review articles. He has advised provincial and federal governments on policy issues related to Assisted Human Reproduction, he has chaired expert working groups for Health Canada and currently chairs a CSA subcommittee on donor sperm, eggs and embryos. He was an inaugral member and spokesperson for the Stem Cell Oversight Committee of CIHR. He holds or has held grants from the MRC (CIHR), Health Canada and the pharmaceutical industry. His research has focused on treatments to improve the outcomes and safety of infertility therapy.

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morality, safety and public health. Provincial governments, for their part, are authorized to regulate and promote health. The Quebec government argued that assisted human reproduction was a provincial responsibility. The Supreme Court of Canada agreed with Quebec and found that the federal government had exceeded its authority.

Ethics and Assisted Reproduction Technologies in Canada: 2004-2014 by Françoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy, Dalhousie University

It has been more than ten years since the Assisted Human Reproduction Act (AHR Act) was enacted. At the time, a number of Canadians (some with vested interests) objected to parts of the Act. There was, however, general support for the idea that federal oversight was needed to protect the health and safety of those who availed themselves of reproductive technologies and of those who were born of these technologies.

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Since then, the AHR Act has been eviscerated. While prohibitions on a range of activities including human cloning, creating embryos of a particular sex, and purchasing reproductive material remain in force, most of the sections aimed at protecting the health of women and promoting the health of offspring have been eliminated. This is because in December 2010 the Supreme Court of Canada found most sections of the AHR Act to be unconstitutional. The federal government subsequently acted to introduce sweeping changes that reached beyond what was required to comply with the Court decision. In Canada, the federal government is authorized to make laws to protect

One important change following this court decision was the elimination of two federal requirements: (i) that fertility clinics collect and manage health reporting information about gamete donors, and (ii) that the federal Agency, Assisted Human Reproduction Canada, maintain a national registry of this information. The purpose of this registry was to manage potential harms to health and safety. A benefit of this registry is that it would have facilitated research to benefit women, couples and children. This change in law means that many Canadians born of assisted human reproduction may never have access to genetic and medical information about those who provided the reproductive material used to create them.

Since the AHR Act has been eviscerated, most of the sections aimed at protecting the health of women and promoting the health of offspring have been eliminated.

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Decision-making around the disposition of embryos is difficult and it appears that at least some Canadians cope with this difficult choice by delaying decision-making. Important parts of the AHR Act are still in force, however, including the prohibitions on the commercialization of assisted human reproduction. To date, there has been one successful investigation in Canada into alleged violations of the Act. This investigation focused on Ms. Leia Picard (sole director of Canadian Fertility Consulting Ltd.). Ms. Picard admitted to violating the prohibitions on paying women to be surrogate mothers, accepting payment for arranging for the services of a surrogate mother, and purchasing eggs. For this, she was fined a total of $60,000. She is still in business today.

The commodification of human reproductive material is but one of many controversial ethical issues, however. Another such issue, which also has to do with money, concerns public funding of IVF. In August 2010, Quebec became the first province to fully fund IVF, up to three stimulated and six unstimulated cycles. In early 2014, Ontario promised to contribute to the cost of one IVF cycle and New Brunswick announced plans to invest $1 million in fertility treatment. At the heart of the debate about public funding is whether infertility is a medically necessary intervention and whether this is the only way to reduce the multiple pregnancy rate. Most recently, in November 2014, the Quebec government decided to scale-back its public funding programme. In the future,

Quebeckers who purchase IVF will be eligible for a tax credit on a sliding scale, depending upon their income. No doubt, access to IVF will continue to be debated in this country. Having said that, in recent years there has been improved access for LGBTQ people. Another hotly contested issue in Canada in the past few years, rendered all the more important because of the fact that there is no national registry collecting and managing health reporting information of gamete donors, is donor anonymity. Much of that debate has centered around the case involving Olivia Pratten – a woman conceived through the use of donor sperm who wanted donor conceived individuals to have access to identifying and medical information about their progenitors. In opposition to Pratten, some insisted that the promise of anonymity was crucial for maintaining an adequate supply of sperm. Others wanted children born of donor gametes to have the option of accessing medical information, but not personal information. As well, there were families who worried that known

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gamete donors might want to insert themselves into the family. These individuals were among those advocating for changes to parentage laws. Issues of parentage and nationality are now taking on added importance in light of the emerging business of transnational reproductive travel which involves the movement of people and reproductive material across national borders to access reproductive technologies. The reasons for this are many and varied. For example, some want access to IVF at a lower cost, others want gametes with particular genetic traits, and still others want to circumvent the legal prohibition on purchasing eggs and gestational services. The ethics of transnational reproductive travel are particularly complicated when the activities pursued abroad are illegal in Canada. In this regard, concerns about the health and well-being of the women who provide the reproductive material (i.e., eggs) or services (i.e., gestation) are front and center.

More recently, ethical questions have been raised about egg freezing. This was originally developed as a fertility preservation option and is now being promoted and provided as an option for young women who choose to delay childbearing. Non-medical egg freezing is not yet common practice in Canada, but there is reason to think this might become more popular in the wake of recent announcements by Facebook and Apple to provide egg freezing as part of their employee benefit package.

them. Decision-making around the disposition of embryos is difficult and it appears that at least some Canadians cope with this difficult choice by delaying decision-making. This has raised questions for Canadian IVF clinics because there is no legal limit on storage. For how long should a clinic maintain an embryo in storage? Could this be in perpetuity? Clearly, assisted human reproduction raises a number of complex ethical issues. As we say in French, this is but a brief “apercu.” © Françoise Baylis

A last theme worth mentioning is increased concern about the disposition of frozen embryos that are no longer wanted for reproductive purposes by the person(s) for whom they were created. The options are to donate these embryos to another person(s) for their reproductive use, to donate them to the clinic for instruction or improving assisted reproduction, or to donate them to research or to discard

About the Author

Francoise Baylis is a leading scholar in the field of bioethics, who has made contributions across a range of areas, including women’s health, assisted human reproduction, feminist ethics, novel technologies, and research involving humans. Through her innovative work, her significant research achievements, her scholarly writing, and her contributions to the development of public policy, she has helped to raise and address critical questions in modern health and science policy.

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Créons des familles • SPRING/PRINTEMPS 2015

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10th ANNIVERSARY ISSUE ••10e ANNIVERSAIRE

LE TEST MATRIS : MD

un NOUVEL OUTIL pour évaluer les chances de succès

Créons de familles : Qu’est-ce que le test Matris ? MD

Roger Pierson : Le mot « matris » signifie mère en latin. Le test MatrisMD est une technique d’imagerie qui, à partir d’une image échographique standard de la paroi de l’utérus au moment de la collecte des ovules, crée une image en 3-D constituant une représentation mathématique des

Entrevue avec le Dr Roger Pierson, professeur au Département d’obstétrique, gynécologie et sciences de la reproduction au Collège de médecine, Université de la Saskatchewan, et inventeur du test MatrisMD

THE MATRIS TEST: ™

A NEW TOOL to Help Predict the Chances of Pregnancy 58

Créons des familles • SPRING/PRINTEMPS 2015

Interview with Dr. Roger Pierson, Professor at the Department of Obstetrics, Gynecology and Reproductive Sciences, College of Medicine, University of Saskatchewan and inventor of the Matris™ test

Creating Families: What is the Matris™ test? Roger Pierson: The word “matris” means mother in Latin. The Matris™ test is an imaging technique that, from a standard ultrasound image of the lining of the uterus at the time of egg retrieval, creates a 3-D image that is a mathematical representation of the

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aspects qualitatifs et quantitatifs de l’endomètre – la paroi de l’utérus. C’est l’un des éléments d’une vaste équation qui nous permet de prédire le degré de réceptivité de l’endomètre et, par conséquent, les probabilités qu’un embryon s’implantera au cours d’un cycle de FIV. La qualité de la paroi de l’utérus est un facteur important pour la succès d’un transfert d’embryon. Notre test vise à optimiser le potentiel de vie de chaque embryon de qualité.

Pour que l’embryon puisse s’implanter, l’endomètre doit être « à point ».

Créons de familles : De quelle façon ? Roger Pierson : Imaginez l’embryon comme une semence et l’endomètre comme le sol où elle va pousser. Pour que

qualitative and quantitative aspects of the endometrium – or the lining of the uterus. It is one of the pieces of a larger equation that allows us to predict the state of receptivity of the endometrium and thus the probability that an embryo will implant during an IVF cycle. The quality of the endometrial lining is a significant factor in a successful embryo transfer. Our test is designed to help optimize the life creating potential of every quality embryo.

qui tapisse la face interne de l’utérus

certain thickness and blood supply that make it perfect for Endomètre : couche interne implantation. The de l’utérus, riche en sang et quality of the autres nutriments endometrial lining and the quality of the embryo are the two main factors for optimal fertility. During each cycle, the endometrial lining changes in response to reproductive hormones. In order for the embryo to implant successfully in the uterus, the endometrium has to be “just right”. The Matris™ test allows us to look at the pixels in an image of the endometrium. We enhance those pixels to better understand the endometrium’s physiology. The mathematical model developed has evolved and is translated into a 10-point scale. A score between 0 and 4 from a Matris™ test indicates the endometrium will be of poor quality, with very little to no chance of a Placenta

The quality of the

endometrial lining and the quality of the embryo are

Creating Families: How so? Roger Pierson: Think of the embryo as the seed and the endometrium as the soil where it grows. In order for the embryo to implant successfully in the uterus, the endometrium has to have a

l’embryon puisse s’implanter avec succès dans l’utérus, l’endomètre doit posséder une épaisseur et un afflux sanguin qui le rendent idéal pour l’implantation. La qualité de la paroi endométriale et la qualité de l’embryon sont les deux éléments clés d’une fertilité optimale. Au cours de chaque cycle, la paroi endométriale change en réaction aux hormones de reproduction. Pour que l’embryon puisse s’implanter, l’endomètre doit être « à point ». Le test MatrisMD nous permet d’examiner les pixels d’une image de l’endomètre. Nous faisons ressortir ces pixels pour mieux comprendre la physioPérimètre : logie de l’endomètre. membrane qui recouvre Le modèle mathémal’extérieur de l'utérus tique mis au point a évolué et se traduit Myomètre : par une échelle de 0 à couche musculaire

the two main

factors for optimal fertility.

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Atlantic Assisted Reproductive Therapies

Achieving Our Mission: To provide excellence in fertility care All Results from the 2012 Canadian ART Registry (CARTR)

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ALL AGES 48 32 (14-48)

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Des résultats du test de MatrisMD entre 7.5 et 10 indiquent que les probabilités de grossesse sont élevées ou très élevées si un embryo d’excellente qualité est transféré. Endomètre normal

10. Un résultat de 0 à 4 indique que l’endomètre sera de piètre qualité, avec peu ou pas de chance de grossesse au cours du cycle de FIV, même si la patiente se fait transférer un embryon d’excellente qualité. Cela ne signifie pas nécessairement que l’endomètre de la patiente sera toujours de mauvaise qualité. Cela signifie que son endomètre n’est pas prêt pour l’implantation au cours du cycle envisagé. Des résultats du test de MatrisMD entre 7.5 et 10 indiquent que les probabilités de grossesse sont élevées ou très élevées si un embryo d’excellente qualité est transféré. Créons de familles : L’endomètre d’une patiente présente-t-il toujours les mêmes caractéristiques ? Roger Pierson : Non. La qualité de

Matris™ test mean

pregnancy occurring during an IVF cycle, even if the patient has an excellent quality embryo transferred. This does not necessarily mean that the patient’s endometrium will always be of poor quality; it means that her endometrium is not ready for implantation in the cycle being considered. Scores that range from 7.5 to 10 on the Matris™ test mean that there is a high to very high probability of pregnancy when an excellent embryo is transferred.

that there is a high to

Creating Families: Will the endometrium always be the same in each cycle?

very high probability

Roger Pierson: No. The quality of the endometrium varies from cycle to cycle, from patient to patient and with each drug used. It is from this reality that the predictive capability of the Matris™ test reveals its true value; we are able to predict whether an optimal endo-

A normal endometrium

Scores that range from 7.5 to 10 on the

of pregnancy when an excellent embryo

l’endomètre varie d’un cycle à l’autre, d’une patiente à l’autre et selon les médicaments utilisés. C’est à partir de cette réalité que le pouvoir de prédiction du test MatrisMD prend tout son sens : nous sommes en mesure de prédire si un endomètre optimal se formera au cours d’un cycle particulier avant même que l’endomètre ne se soit pleinement développé. Ceci permet aux médecins et à leurs patients de prendre de meilleures décisions. Créons de familles : Le test Matris est-il déjà disponible dans les cliniques ?

Roger Pierson: Plusieurs cliniques de toutes les régions du Canada l’utilisent déjà. Notre équipe prévoit une expansion vers les États-Unis et l’Europe dans les mois qui viennent.

metrium will develop during a particular cycle in advance of the endometrium more fully developing. This allows physicians and their patients and to make better decisions. Creating Families: Is the Matris™ test available in fertility clinics already? Roger Pierson: Several clinics are using it already across Canada. Our team will be expanding to the US and Europe in the coming months. Different pieces of our technology have actually been used in clinical trials by pharmaceutical companies for several years. However, the Matris™ test represents the first time fertility clinics will be able to access this same technology. The way it works is that physicians upload the required image to our secure computers. Our team performs the analysis and a report is communicated back to the clinician. This usually all happens within

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Divers éléments de notre technologie sont employés par les compagnies pharmaceutiques lors d’essais cliniques depuis plusieurs années. Cependant, avec le test MatrisMD, c’est la première fois que les cliniques de fertilité auront accès à cette technologie, qui fonctionne de la manière suivante : le médecin télécharge l’image requise dans nos ordinateurs sécurisés. Notre équipe procède à l’analyse et envoie son rapport au médecin. Ce processus se déroule en l’espace de 36 heures ou de un à trois jours avant le transfert de l’embryon. Ainsi, les réponses fournies sont à la fois pertinentes et livrées au moment opportun. Par exemple, au cours d’un cycle frais, si le score est élevé le médecin peut se sentir à l’aide de procéder à un transfert, alors que si le score est faible, il ou elle pourra décider qu’il vaudrait mieux thirty-six hours or one to three days prior to embryo transfer. So, the answers provided are not only relevant, but also timely. For example, during a fresh cycle, if the score is high the clinician can be comfortable with proceeding with a transfer, while if the score is low he or she may decide that it would be better to freeze the embryos and transfer them when the endometrium is better prepared. On the other hand, let’s suppose a physician is performing a mock embryo transfer cycle; if the score is low, he or she can modify the medication accordingly, and if the score is high the clinician will know that the same procedure may be used for subsequent cycles.

L’un des domaines de compétence qui nous est propre est la fusion de la technologie d’imagerie, de la

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Créons de familles : Quel accueil cette technologie a-t-elle reçu ?

science informatique et de la procréation. Image échographique d’une vue transversale de l’utérus servant à crééer l’image en 3-D.

Typical ultrasound transverse image of the uterus from which the 3-D image is created.

One of our unique areas of expertise is the merging of imaging technology, computer science and reproduction.

Creating Families: How has this technology been received by clinics?

congeler les embryons et les transférer lorsque l’endomètre sera mieux préparé. Par ailleurs, supposons qu’un médecin simule un cycle de transfert : si le score est faible, il pourra modifier la médication en conséquence, et si le score est élevé il saura que la même procédure pourra être appliquée aux cycles subséquents.

Roger Pierson: Je suis très heureux de la réaction en général. Nous ne faisons pas affaire directement avec les patients, mais le suivi auprès des cliniques montre que la réaction des patientes est très positive. Elles n’ont pas besoin de subir une biopsie, et les résultats du test s’appliquent au cycle en cours. Ces deux avantages signifient beaucoup pour les Roger Pierson: Overall, I have been very pleased with the reaction. While we only interact directly with the fertility clinics and not the patients, we understand from follow-up conversations that the patient response has been very positive. There is no need for a patient to undergo a biopsy and the test result is applicable to the current cycle. Both of these benefits mean a lot to patients. In addition to providing these relevant results to the physicians, we collect and analyse data continuously so we are able to provide additional services to the clinics as the technology is incorporated into specific practices. With respect to results, the final data will not be in for another year, one reason being that each patient is unique. We’ll have to classify the various types of patients and create statistics. The good news is that we had excellent results during the clinical trial even with day-3 embryos, as this was before

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patientes. En plus de fournir des résultats pertinents aux médecins, nous recueillons et analysons des données continuellement, de sorte que nous pouvons dispenser d’autres services aux cliniques à mesure que la technologie est intégrée à des pratiques spécifiques. Pour ce qui est du bilan du test MatrisMD, les données finales ne seront pas connues avant un an, notamment parce que chaque patiente est unique. Nous devrons classer les patientes selon diverses catégories et générer des statistiques. La bonne nouvelle est que nous avons obtenu d’excellents résultats lors de l’essai clinique, même avec des embryons de trois jours, étant donné que l’utilisation des blastocystes n’était pas courante à l’époque. Et les données de l’essai sur le terrain sont très semblables jusqu’à présent même si, contrairement à un essai clinique où les blastocysts were widely used. And the results from the field trial so far have been strikingly similar, even though, unlike a clinical trial where we deal with ideal patients, a field trial involves patients of all kinds, including those with a poor prognosis. Creating Families: Can the Matris™ test be used with inseminations? Roger Pierson: Yes. Some of the very first iterations of the test were done in research work with patients undergoing intrauterine inseminations. It is helpful in this context because the success of IUIs depends on the synchronicity between the development of the uterine lining and that of the ovary. During the follicular phase of the cycle and during ovarian stimulations, a woman’s ovaries change as her follicle(s) develop and so does the lining of the uterus. There will be a better chance of a pregnancy if the ovarian

patientes sont triées sur le volet, un essai sur le terrain implique des patientes de toutes catégories, y compris celles dont le pronostic est défavorable. Créons de familles : Le test MatrisMD peut-il être employé pour les inséminations ?

Roger Pierson: Oui. Les premiers essais du test ont été effectués lors de travaux de recherche dans le cadre d’inséminations intra-utérines. Le test est utile dans ce contexte parce que le succès des inséminations dépend de la synchronicité entre le développement de la paroi utérine et celui de l’ovaire. Au cours de la phase folliculalire du cycle et pendant les stimulations ovariennes, les ovaires d’une femme changent à mesure que son(ses) follicule(s) se développe(nt), et il en va de même pour response is perfectly synchronized with the endometrial response. Creating Families: Why do you think this tool was not created earlier? Roger Pierson: Over the years, I think that all of us in the infertility field worked so hard for so long to produce the best embryo possible that the endometrium received less attention. The other reason is that there are very few people in the world working on game-changing imaging techniques in reproduction. My background is in reproductive endocrinology and imaging. One of our unique areas of expertise is the merging of imaging technology, computer science and reproduction. The fundamental technology we developed has been, and continues to be, used by pharmaceutical companies; it simply took some creativity on our part to figure out a way to get these predictive capabilities into the hands

of physicians around the world who are dealing with actual IVF patients on a daily basis. The evolving use of new technologies inside these clinics and the ability to combine them with our own technology provided us with the right timing, circumstances and motivation for clinics and patients to request that the Matris™ test be made available to them. It also helps to live in Saskatoon and look at images all day inside because it’s just too cold outside… I have had the privilege of benefitting from grants from the Medical Research Council of Canada in the early years as well as the Canadian Institutes of Health Research more recently. Much of the background research that has led to this technology was developed with the help of these grants. I am so very grateful to the Canadian medical research system and the Canadians who contribute to new

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la paroi de l’utérus. Les chances de grossesse sont meilleures si la réponse ovarienne est parfaitement synchronisée avec la réponse de l’endomètre. Créons de familles : Pourquoi cet outil n’a-t-il pas été inventé plus tôt selon vous ? Roger Pierson: Je pense qu’au fil des ans tous ceux d’entre nous qui œuvrons dans le domaine de l’infertilité ont mis tellement d’efforts pendant si longtemps pour produire le meilleur embryon possible que l’endomètre a reçu moins d’attention. L’autre raison est qu’il y a très peu de gens dans le monde qui se penchent sur les techniques d’imagerie innovatrices en matière de procréation. J’ai une formation en endocrinologie de la reproduction et en imagerie. L’un des domaines de compétence qui nous est

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propre est la fusion de la technologie d’imagerie, de la science informatique et de la procréation. La technologie fondamentale que nous avons mise au point a été, et est encore, utilisée par les compagnies pharmaceutiques. Il a simplement fallu un peu de créativité de notre part pour trouver un moyen de mettre cette capacité de prédiction entre les mains des médecins à travers le monde qui traitent des patientes de FIV tous les jours. L’utilisation croissante des nouvelles technologies dans les cliniques et la possibilité de les combiner avec notre propre technologie ont fait en sorte que le moment et les circonstances étaient propices à inciter les cliniques et les patients à réclamer l’accès au test MatrisMD. Ça aide aussi de vivre à Saskatoon et de regarder des images toute la journée parce qu’il fait trop froid dehors…

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J’ai eu le privilège de bénéficier de subventions du Conseil de recherches médicales du Canada au début de mes travaux, ainsi que des Instituts de recherche en santé du Canada plus récemment. Une grande partie de la recherche de base ayant conduit à cette technologie a été effectuée grâce à ces subventions. Je suis extrêmement reconnaissant au système de recherche médicale du Canada et aux Canadiens qui contribuent à ces nouvelles découvertes. C’est cette générosité qui nous a permis de mener ces travaux au cours des quelque 20 dernières années et d’offrir cette nouvelle technologie au Canada et au reste du monde. Nous avons fait le choix de mettre le Canada en tête de liste et d’offrir le test MatrisMD aux cliniques canadiennes et à leurs patientes, et aussi d’aider les cliniciens à fournir d’excellents soins personnalisés à leurs patients.

discoveries. It is this generosity that has allowed us to conduct this work over the last 20 plus years and bring this new technology to clinics in Canada and the rest of the world. We have made the choice to put Canada first in providing the Matris™ test to Canadian clinics and their patients, as well as play a vital role in assisting clinicians in providing excellent personalized patient care.

Le succès des inséminations dépend de la synchronicité entre le développement de la paroi utérine et celui de l’ovaire. The success of IUIs depends on the synchronicity between the development of the

Au sujet du Dr Pierson Roger A. Pierson, MS PhD FEAS FCAHS, est professeur au Département d’obstétrique, gynécologie et sciences de la reproduction au Collège de médecine de l’Université de la Saskatchewan. Après avoir terminé son Ph.D. en endocrinologie et physiologie de la reproduction à l’Université du Wisconsin à Madison en 1987, il a obtenu plusieurs postes de chercheur (Académie européenne des sciences en 2002, Institut canadien de médecine académique en 2004 et Académie canadienne des sciences de la santé en 2005). Il est actuellement le président et directeur scientifique de Synergyne, Incorporated, à Saskatoon, en Saskatchewan. Auteur de nombreuses publications, ses recherches portent principalement sur les soins de santé génésique destinés aux femmes, l’imagerie échographique et par résonance magnétique de même que sur la fonction ovarienne en procréation assistée.

About Dr. Pierson Roger A. Pierson, MS PhD FEAS FCAHS, is a Professor at the Department of Obstetrics, Gynecology and Reproductive Sciences of the College of Medicine of the University of

uterine lining and

Saskatchewan. After completing a PhD in Reproductive Endocrinology and

that of the ovary.

Physiology at the University of WisconsinMadison in 1987, he obtained several fellowships (European Academy of Sciences in 2002, Canadian Institute of Academic Medicine in 2004 and the Canadian Academy of Health Sciences in 2005). He is currently the President and Chief Scientific Officer of Synergyne, Incorporated, in Saskatoon, Saskatchewan. A widely published author, his main academic interests focus on women’s reproductive health care, ultrasonographic and magnetic resonance imaging as well as ovarian function in assisted reproduction.

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Lab BREAKTHROUGHS of the Decade Interview with Dr. Marie-Claude Léveillé, Scientific Director of the Ottawa Fertility Centre

Creating Families: What do you think was the most significant breakthrough of the past decade with respect to laboratory techniques? Marie-Claude Léveillé: The development of the freezing method called vitrification is certainly the one which will have the greatest impact in the long term. Vitrification opened the door to a better way of freezing oocytes and embryos. With the former technique of slow freezing, the

survival rate of embryos was not optimal but it was nevertheless acceptable; however, few eggs survived this process because slow freezing allowed for many ice crystals to form. Vitrification has greatly increased the survival rate of oocytes upon warming. It is therefore possible nowadays to preserve the fertility of women with cancer – who may have their eggs vitrified before chemotherapy treatments – or the fertility of women who wish to delay motherhood for whatever reason. Before the advent of vitrification, the slow freezing method for freezing oocytes created a barrier for women. Creating Families: Is vitrification now used for sperm as well? Marie-Claude Léveillé: Slow freezing is still used for sperm, because even if only 50% of spermatozoa do not survive thawing, we are still left with millions of them – more than enough to produce a pregnancy. Vitrification of a number of selected sperm is an option that is being increasingly talked about, in particular for severe male factor specimens, but this is a development down the road. Creating Families: What would be the second most important development in the last 10 years? Marie-Claude Léveillé: Remarkable advances in the quality of culture media is what has been dominating the field of embryology during the past decade. We now grow embryos successfully until Day 5 or Day 6. This allows us to select the best embryo for transfer. It is a most important development as the possibility to identify and transfer the most viable embryo is an important step toward reducing the number of

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The development of the freezing method called vitrification is certainly the breakthrough which will have the greatest impact in the long term.

developments since the intracytoplasmic sperm injection? Marie-Claude Léveillé: ICSI was a true revelation over 20 years ago. Among other things, it made possible the retrieval of sperm from the testicle and the

multiple births. It also helps to lower the rate of miscarriages. Moreover, the technique of time-lapse photography, which has made great progress over the past two years, will considerably improve the methods used for embryo culture. With time-lapse photography, photos of the embryos are taken every few minutes in an undisturbed environment, as it is no longer necessary to take the embryos out of the incubator. Consequently, their development is more closely monitored and this, again, helps in selecting the best single embryo for transfer. Several clinics are now offering time-lapse photography. Creating Families: Regarding IVF, have there been important

injection of that sperm into the oocyte. The technique has not really changed over the last 20 years, and it works well. The only new development has been the Intracytoplasmic Morphologically Selected Sperm Injection – IMSI – developed in Israel. It involves the following: before the sperm is injected into the ovum, several spermatozoa are examined using high magnification. The objective is to select the sperm with the best morphological features. This technique is not yet routine, but

practitioners are increasingly aware of its existence. The only drawback is that it is time-consuming since each sperm has to be looked at individually. Of course, Comprehensive Chromosomal Screening of embryos, which my colleague Jeff Haebe discusses in this issue, is another important development, as will be the freezing of ovarian tissue. Thanks to this technique, we will be able to freeze a number of ovaries of young girls at risk of losing their fertility. Their oocytes will not be mature at the time of freezing, therefore what we will be doing, really, is growing their follicles in vitro. This technique is not yet available in fertility clinics, but many studies are being conducted on animals. At the moment, physicians reimplant ovarian tissue in women at an appropriate moment, but down the road we will likely see the freezing of ovarian tissue coupled with in vitro growth, maturation and fertilization. About Dre Léveillé

Dr. Marie-Claude Léveillé completed a Bachelor of Science degree in Biochemistry and then earned her PhD in Clinical Sciences, both at the University of Montreal. Having completed her fellowship training in Reproductive Biology at the University of Western Ontario, she joined the Fertility Centre at the Ottawa Hospital in 1988. Dr. Léveillé is currently an Assistant Professor of Obstetrics and Gynecology at the University of Ottawa, an Affiliate Investigator at the Ottawa Hospital Research Institute and the Scientific Director of the Ottawa Fertility Centre. She is a founding member of the ART Lab Special Interest Group of the Canadian Fertility and Andrology Society, and was its President from 2011 to 2012. Dr. Léveillé has received awards for excellence for the development of IVF standards for use in accreditation of laboratories in Canada, and for research in reproductive biology. She has served as a member of various expert working groups for the Canadian government on all aspects of assisted human reproduction.

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FREEZING TIME with Fertility Preservation

by Kristi Maas, MD, ME Boston IVF

If you are reading this, chances are you are someone who may be interested in having children at some point in your life. You may not necessarily be at that point today – you may never reach that point – but don’t put this article aside; it is intended for you! Now is the best time inform yourself, consider your options, and take action if you want to.

Deciding when or if you want to get pregnant As women we have competing interests with respect to our fertility. We desire to prevent pregnancy until a time we feel ready, but we also want to easily become pregnant when we are ready.

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With advancing age at first born, more women are faced with infertility. After many years of hiding these struggles due to fear or shame, patients with infertility are finally sharing their stories and the problem is well recognized. With this recognition comes a call for action. Women are motivated to prevent this difficult diagnosis.

Why your age matters Because a woman is born with all of the eggs she will ever have and these eggs are lost over time it is clear that time and, therefore, age play an important role in fertility. In addition to a decreased supply, the remaining eggs from older women are more likely to be chromosomally abnormal as her age increases. Chromosomes contain genetic material that is passed from a parent to a child and chromosomally abnormal pregnancies are less likely to lead to a live birth. It is estimated that approximately 5% of a 25-year-old woman’s eggs are chromosomally abnormal whereas 10-25% are abnormal among women in their thirties. 1,2,3,4 This number rises significantly

As women we have competing interests with respect to our fertility. We desire to prevent pregnancy until a time we feel ready, but we also want to easily become pregnant when we are ready. to 50% or higher for women in their forties.1,2,3,4 The increasing rate of abnormalities is due to the process of egg maturation and development prior to fertilization with sperm.

As a result of the decreasing number of eggs and the increasing number of chromosomally abnormal eggs, the average woman’s fertility gradually declines until approximately age 37 at which time it begins to decrease more precipitously.

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What can affect your ovaries and how well they work?

door to fertility preservation for women who desire to delay childbearing for personal or professional reasons. Many women find this an empowering option, allowing them to essentially stop their biological clock and taking the pressure off of creating a family “before it’s too late.”

Genetic conditions such as Fragile X Syndrome and Turner’s Syndrome (45X0) are known to be associated with loss of egg number and quality at younger ages. Eggs can also be injured or prematurely depleted by treatments termed “gonadotoxic.” Gonadotoxic therapies include select medications such as chemotherapy, radiation, surgery to the ovaries or treatments affecting the blood supply to the ovary, or significant long-term health conditions. When a woman faces a diagnosis of a serious chronic medical condition, cancer, or the need for gynecologic surgery she should be counseled about the reproductive risks of her disease and/or treatment. We know that radiation and chemotherapy are gonadotoxic, meaning they injure the ovaries and eggs, and that the effects depend upon the amount of the gonadotoxin and the age of the woman when she is treated. As a woman’s age at treatment increases, relatively smaller doses of the gonadotoxin will result in a more significant loss of egg number and/or quality. The treatment of pediatric, adolescent, and young adult cancers has become more effective and survivors have longer life expectancies. This underscores the need for discussion of the effects of therapy on fertility and the preservation of fertility prior to treatment.

How to choose when to preserve your fertility?

Many women find egg freezing an empowering option, allowing them to essentially stop their biological clock and taking the pressure off of creating a family “before it’s too late.” The use and success of egg freezing in patients facing gonadotoxic therapies has opened the

Regardless of the reason a woman decides to preserve her fertility, the best time to do it is now. It is clear that fertility declines with age and it is impossible to know how long a woman’s fertility will remain functional. Each woman’s fertile window – the time where she is able to become pregnant naturally – is different. The window is affected by multiple factors including health, family history, exposure to gonadotoxins, and even other currently unknown factors. At this time, closure of a woman’s fertile window can’t reliably be predicted.

Can you find out how well your ovaries will respond? Despite the inability to determine when a woman’s fertile window will close, testing can be done to predict how she will respond to medications used to stimulate her ovaries. These medications were initially used for in vitro fertilization (IVF) and are now being used for egg freezing, as well. The testing is called ovarian reserve testing and is generally

Can we preserve fertility? Previously, many women facing gonadotoxic therapy were given neither information nor the option to undergo fertility preservation. When the information was provided the only available method to preserve female fertility was to freeze embryos. This created a significant dilemma for single women or women not in a committed relationship. The introduction of egg freezing now allows women to preserve their fertility independently.

Legal advice and guidance to prospective parents, donors and surrogates Christopher Deeble (613) 830-4445 www.ottawafertilitylaw.com

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Regardless of the reason a woman decides to preserve her fertility, the best time to do it is now.

These tests are interpreted together to estimate a woman’s ovarian reserve. The tests do not predict a woman’s window of fertility nor is their utility in non-stimulated (IVF or egg freezing) settings fully understood at this time.

What is the preservation process like?

able to go home the same day. During the procedure, a physician uses ultrasound to find the woman’s ovaries and guides a needle into each developing follicle where the eggs are carefully removed. An embryologist identifies each egg, prepares it for freezing, and then freezes the egg. These eggs are frozen in time and will always reflect the woman’s age at the time they were frozen, not the age of the woman when they are thawed and used.

done on day three of the menstrual cycle where day one is considered the first day of flow.

When a woman is ready to use her eggs, they are thawed, fertilized with sperm, and then transferred back into her uterus during a quick procedure called an embryo transfer.

An ultrasound can be performed to look at the number of follicles within each ovary and calculate an antral follicle count – the total number of measurable follicles.

Are there any long term effects of the process?

Blood can be drawn to test for follicle stimulating hormone (FSH), estradiol (E2), and anti-mullerian hormone (AMH). Follicle stimulating hormone is released from the brain and stimulates the ovary to develop follicles and the eggs within them. Estradiol is checked in conjunction with follicle stimulating hormone. It is produced from the ovary and it assists in the interpretation of follicle stimulating hormone levels. Antimullerian hormone is cycle independent, meaning that it can be checked at any time during the menstrual cycle. It is another marker used to estimate the pool of resting follicles within the ovary.

Patients who desire to have their eggs frozen will undergo a process called controlled ovarian hyperstimulation. This involves taking injectable medications on a daily basis to stimulate the ovaries to develop multiple follicles. The woman will be monitored with vaginal ultrasounds and blood tests until her developing follicles have grown adequately. At that time, the patient will give herself a final injection, called the trigger shot, that helps prepare the eggs within the developing follicles for retrieval. Approximately 36 hours after the trigger shot, the patient will have the eggs removed in a quick procedure and will be

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Research has shown that embryos created from egg donors where eggs are collected and frozen, then stored until desired use when they are thawed and fertilized, have equivalent outcomes to embryos from eggs that were not frozen prior to fertilization.5 The potential of the frozen eggs to become a baby depends upon a woman’s age at the time of egg freezing, her ovarian reserve, and her health history. This will remain the same regardless of how long the eggs are frozen as they are essentially suspended in time. The medications used for egg freezing have been used for decades in the treatment of infertility with IVF and have not been shown to have long term risks. Additionally, babies born through IVF processes – which in most ways are the same as using frozen eggs – do not have an increased risk of birth defects or disorders above the risk that occurs with spontaneous pregnancies. The egg freezing process does not decrease a woman’s egg supply. The medications she takes during the cycle rescue follicles that would otherwise die off when the primary

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follicle is selected and keep them alive to develop multiple useable eggs. The process does not steal eggs from future menstrual cycles.

Opinions from experts in the field Increasing acceptance for egg freezing came in January of 2013 and January of 2014 when three well recognized fertility and OB/GYN societies (ASRM, SART, and ACOG) released statements that egg freezing should no longer be considered experimental.6,7 The societies endorse the practice of egg freezing for patients undergoing gonadotoxic treatment. They state that further evidence is required before recommending egg freezing specifically for use by patients who wish to electively defer childbearing as there is insufficient data to confirm its utility. This lack of data is primary a result of the newness of the technique and the small numbers of patients undergoing egg freezing previously.

Fertility preservation is catching on Recently, egg freezing has become more mainstream in society, as well. Insurance companies are regularly covering the cost of fertility preservation for patients undergoing gonadotoxic therapies and now technological companies such as Facebook and Apple are paying for their employees to electively have their eggs frozen. Some worry that this may be seen as encouraging women to delay childbearing and focus on their careers while others feel this is a liberating opportunity for women to uncouple reproduction from age. The long-term effects remain to be seen, but women who are interested should investigate the opportunity as well as their insurance coverage options. As a thirty-three year old female who works

in the field of reproductive endocrinology and who has seen the devastating impact of infertility I have chosen to electively freeze my eggs. I don’t now what the future holds for me, but I feel more secure knowing that I have placed my fertility on ice and not left it to chance.

As a thirty-three year old female who works in the field of reproductive Online 2009;19:228-237.

endocrinology and who has seen the devastating impact of infertility I have chosen to electively

5. Sekhon et al. Frozen versus fresh donor egg IVF: simi-

lar efficacy and greater efficiency in a large donor egg IVF program. Fertil Steril 2014;102(3):e83. 6. ACOG: Committee Opinion No. 584: oocyte cryop-

reservation. Obstet Gynecol. 2014 Jan;123(1):221-2. 7. Mature oocyte cryopreservation: a guideline. Practice

more secure knowing

Committees of American Society for Reproductive Medicine, Society for Assisted Reproductive Technology. Fertil Steril. 2013;99:37-43.

that I have placed my

About the Author

freeze my eggs. I feel

fertility on ice.

Dr. Kristi Maas is a Fellow in Obstetrics, Gynecology, and Reproductive Biology at Beth

References: 1. Sandalinas M, Marquez C, Munne S. Spectral kary-

Israel Deaconess Medical Center and Boston IVF. She is a Gynecologic Staff Attending at Beth Israel Deaconess Medical Center affiliated

otyping of fresh, non-inseminated oocytes. Mol Hum Reprod 2002;8:580-585.

with Harvard Medical School. Dr. Maas is a

2. Pellestor F, Andreo B, Arnal F, Humaeu C, Demaille

and Gynecology and an active member of the

J. Maternal ageing and chromosomal abnormalities: new data drawn from in vitro unfertilized human oocytes. Hum Genet 2003;112:195-203.

American Congress of Obstetricians and

Diplomate of the American Board of Obstetrics

3. Fragouli E, Alfarawati S, Goodall NN, Sánchez-García JF, Colls P, Wells D. The cytogenetics of polar bodies: insights into female meiosis and the diagnosis of aneuploidy. Mol Hum Reprod 2011b;17:286-295. 4. Fragouli E, Escalona A, Gutierrez-Mateo C, Tormasi

S, Alfarawati S, Sepulveda S, Noriega L, Garcia J, Wells D, Munne S. Comparative genomic hybridization of oocytes and first polar bodies from young donors. RBM

Gynecologists, the American Society for Reproductive Medicine, and the New England Fertility Society. She is post-doctoral research fellow with Dr. Kevin Eggan at the Harvard Stem Cell Institute. Dr. Maas's research interests include Polycystic Ovarian Syndrome Physiology, Fertility Preservation, and Neonatal Outcomes after IVF Treatment. Her practice includes all areas of reproductive medicine as well as surgical gynecology.

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Where is Research in Assisted Reproduction

Headed?

The goal of research in human assisted reproduction is to broaden the range of conditions causing infertility that can be successfully treated, to reduce any health risks associated with infertility treatments as well as its financial burden and, most importantly, to ensure that babies born through assisted reproduction are healthy.

by Dr. Hugh Clarke

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Two recent innovations provide good examples. Recognizing that twins and triplets are at higher risk than singletons for complications during pregnancy and after birth, clinics are moving towards single embryo transfer for most women. This means that selecting the embryo with the best chance of developing into a healthy newborn becomes paramount. To identify the best embryo, many clinics no longer transfer newly fertilized eggs into the prospective mother as

soon as possible but instead allow them to develop for several days in the incubator (in vitro – literally, in glass). At this point, the most advanced embryo is selected for transfer, and others can be frozen for future transfer if desired. A second major advance has been improved protocols for egg freezing, termed cryopreservation. Although it has long been possible to obtain healthy children from embryos that were frozen after fertilization and later implanted into the mother, recent progress has enabled physicians to successfully freeze unfertilized eggs, which can later be thawed and fertilized. These important advances have reduced potential risks associated with assisted reproduction for both women and their newborns and enabled fertility preservation to be extended to women without a current male partner.

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First, identify the population in need of help Where is research in assisted reproduction headed today? To answer this question, we need to identify the population who need help that is not yet available. Intense research over the past several decades has led to radically improved cancer therapies, meaning that many young people now survive this disease. Unfortunately, a common side-effect of cancer therapies – especially in the case of women – is infertility. Why these therapies destroy the egg cells remains poorly understood and is an active area of study. One strategy to overcome this problem is to remove and freeze a portion of the ovary before therapy, and then re-implant it in the patient after treatment. Several babies have been born following this procedure, which is clearly a promising approach. However, in the case of aggressive cancers – such as leukemia, which is relatively prevalent among adolescent girls – the cancerous cells may have infiltrated the ovary prior to treatment. For these patients, returning the ovarian fragment carrying the cancer cells is not possible, and another approach is needed. In addition to cancer patients of pre-reproductive and reproductive age, many women suffering from premature ovarian insufficiency (POI) or other conditions that prevent normal functioning of the ovary remain outside the reach of current fertility preservation

Using simple culture conditions, which could be routinely established in virtually any clinic, healthy pups have been born from mouse oocytes that have been grown entirely in vitro. techniques. How can they be helped? In the early days of assisted reproduction, the goal was to remove the egg from the woman, fertilize it, and transfer it to the uterus as quickly as possible. In other words, to keep the time that the egg and embryo spent in the incubator to an absolute minimum. This was sound practice, because the in vitro culture conditions simply weren’t as good as the natural environment of the ovary and uterus. Over time, however, our in vitro techniques have gotten better. Culturing newly fertilized

eggs for three or four days until they reach the blastocyst stage is now routine for many clinics. In addition, some have introduced oocyte maturation in vitro, a technique in which the final stage of egg development occurs in the incubator. Maturation in vitro is particularly promising for women, such as those with polycystic ovaries, who are at risk for ovarian hyperstimulation syndrome. Building on these advances, researchers have begun to ask whether we can use our improved in vitro techniques to help young cancer survivors and those at risk for POI.

Understanding the biology To understand how we may be able to help these women retain fertility, a little background biology is necessary. The ovaries of a newborn girl contain tens of thousands of tiny primordial follicles, each consisting of one oocyte surrounded by supporting cells – think of the follicle as a grape, the oocyte as the seed and the flesh as the supporting cells. Before the oocyte can be ovulated and fertilized, however, both it and its follicle

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then ovarian fragments could be removed from cancer patients prior to therapy or from women at risk for POI, and used as the source of primordial follicles that could be grown to full size in vitro.

Growing oocytes in vitro

Maintaining oocytes until they have completed growth is the current challenge confronting researchers. need to undergo a long period of growth lasting three to four months. Once growth is complete, the oocyte is ready to be ovulated and fertilized. If it isn’t fertilized once it’s reached full-size, it quickly deteriorates and eventually dies.

Why is this knowledge important for rescuing fertility? Unlike a male, who makes new sperm continuously once he reaches puberty, a female makes no new oocytes or follicles after birth. This means that the follicles she is born with have to last throughout her reproductive life, or between 40 and 50 years. So not all of the follicles can begin to grow when she reaches puberty. Instead, only a small number begin to grow at any one time. Most remain in the nongrowing primordial state, until they receive the signal to start growing. When ovarian fragments are re-transplanted into women after cancer therapy, it is the primordial follicles that physicians hope will begin to grow in the months or years ahead, generating fully grown oocytes that can be ovulated and fertilized. Now researchers have begun to ask whether we can find a way to stimulate these primordial follicles to grow in vitro – in the laboratory incubator instead of inside the ovary inside. If so,

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How do we grow oocytes in vitro? First, thin fragments or strips of the ovary containing primordial follicles are placed in plastic petri dishes and bathed in medium containing essential minerals and nutrients to allow growth to begin. A few days later, the growing follicles are identified using a microscope, carefully dissected from the underlying tissue, transferred onto a thin membrane or a fresh plastic petri dish, and then returned to the incubator so that they can continue to grow. Growth can be monitored by measuring the size of the follicle. Using these simple culture conditions, which could be routinely established in virtually any clinic, healthy pups have been born from mouse oocytes that have been grown entirely in vitro. These proof-of-principle studies provide reason for optimism that it should be possible to grow human oocytes in vitro also. In fact, recent studies have identified the trigger that tells small follicles to begin to grow, and drugs that ‘pull’ this trigger have successfully activated human follicle growth in vitro. So we know how to start the process. Maintaining oocytes until they have completed growth is the current challenge confronting researchers. One reason is that because growth is a slow process, it has been difficult especially in the case of primates to keep the oocytes and follicles healthy for such a long time. Different research teams around the world are pursuing different strategies. Some are testing whether embedding the growing follicle in a semi-solid matrix, which allows it to retain its three-dimensional structure, produces healthier oocytes. Others are testing whether a ‘stripped-down’ follicle that consists of just the oocyte and the supporting cells that immediately surround it might work best, because this would allow the nutrients in the culture medium to easily reach the growing oocyte.

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A big challenge is ensuring that oocytes grown in vitro are normal. A bigger challenge is ensuring that oocytes grown in vitro are normal. There is a reason that oocyte growth requires several months – a lot is happening. In addition to increasing more than 100-fold in volume, the growing oocyte also accumulates molecules that will direct the early stages of embryonic development after fertilization, and it undergoes a process called imprinting that influences development of the embryo and even after birth. It is essential that all of these complex and diverse events occur normally when

oocytes are grown in vitro. For example, some researchers have found that oocytes grow more rapidly in vitro than in the ovary. Is this because here is some natural brake in the ovary – needed perhaps to regulate the number of eggs that are ovulated – that isn’t relevant in vitro? Or is it a sign that the growth in vitro isn’t normal? And, since we don’t yet understand all of the changes that occur during oocyte growth, how will we know whether something has gone wrong?

What is certain is that we need continued and coordinated research that on the one hand seeks to identify the changes in a growing oocyte that endow it with the astonishing ability to give rise to a new individual, and on the other hand focuses on using this knowledge to refine and improve our ability to grow oocytes in vitro, bringing hope of fertility preservation to those who wish to start a family. About the Author

Dr. Clarke is Professor and Research Director of the Department of Obstetrics and Gynecology at McGill University, and holds the Richard Cruess Chair in Reproductive Biology. His research centres on understanding the mechanisms that control the development of the mammalian oocyte. Dr. Clarke’s laboratory is supported by grants from the Canadian Institutes of Health Research and the Natural Sciences and Engineering Research Council.

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Multiple Births in Canada: Moving In The Right Direction Interview with Dr. Jason Min, physician and ART specialist at the Calgary Regional Fertility Program

Like many other countries, Canada has redefined success in fertility treatment as the birth of a healthy

Creating Families: What progress has been made over the last decade as to the reduction of multiple births in Canada? Jason Min: We have made remarkable progress in the last few years. Until 2009 the multiple birth rate was quite steady at about 30%. By 2012, it was 16.5%. In November of 2009, Canadian IVF directors, embryologists and other stakeholders took part in a meeting aimed at finding ways of bringing down the rate of multiple births associated

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singleton. with assisted reproduction technologies in Canada. Several targets were established, among them to decrease the twin rate per clinic to 25% by 2012 and to 15% by 2015. Another was to increase the use of single embryo transfer to more than 50% for goodprognosis patients. Much of the reduction in the multiple rate has been attributed to

Quebec, where IVF funding was tied to maintaining a multiple rate of less than 10%. However, the rest of Canada (in which IVF is largely unfunded) has also seen success, with a multiple rate of 20.7% in 2012. Creating Families: How do you explain this situation? Jason Min: Like many other countries, Canada has redefined success in fertility treatment as the birth of a healthy singleton. Fortunately, many fertility specialists acknowledge that the best chance of having a healthy birth is by having one baby at a time. Although many, particularly patients, refuse to believe this, we know that twins are higher-risk. Because of this buy-in, I think fertility doctors are doing a better job of convincing patients of the benefits of having a singleton pregnancy. Also, with several

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improvements in technology including blastocyst culture, embryo assessment and cryopreservation, IVF clinics are getting better at identifying embryos with high implantation rates, transferring fewer embryos at a time and successfully cryopreserving excess embryos for later use. With reductions in the number of embryos transferred, there has been an overall decline in live birth rate per cycle, from 30% in 2009 to 23% in 2012. In women under 35 years of age, those who are most often having an elective single embryo transfer, the live birth rates have declined from 40 to 31% over the same period. In this age group, the live birth rate in 2003 was also 31%. While it may seem that we are taking a step backwards, we are seeing a dramatic decrease in the multiple birth rate. During the same time period, the multiples dropped from 34 to 17% in women under 35. Single embryo transfer is the only way to achieve this reduction in multiple births. The

The Quebec experience showed how dramatically you can reduce the rate of multiple births when you tie IVF funding to a single embryo transfer policy. Quebec experience showed how dramatically you can reduce the rate of multiple births when you tie IVF funding to a single embryo transfer policy. In 2012, the rate of multiples in Quebec from IVF cycles stood at 6%. Creating Families: Has the live birth rate for young women dropped that much in the rest of Canada if you take the frozen embryo cycles into account?

Jason Min: That is a very important question. The true outcome of interest should be the cumulative live birth rate once you add up the outcome of one fresh embryo transfer and one frozen embryo transfer. If you compare that cumulative live birth rate – fresh embryo transfer plus frozen embryo transfer – with the live birth rate associated with transferring two fresh embryos, many studies show a similar live birth rate; however, the chances of delivering a healthy baby are higher transferring one at a time because there will be very few multiples. Creating Families: Is it still difficult to convince patients of this fact? Jason Min: There is still resistance from patients, and this is understandable in a system where the patient pays for IVF. But we are getting smarter about convincing patients. And one can’t argue with medical data. At our clinic, we have succeeded in bringing the rate of multiple births down to 16% while still maintaining an excellent pregnancy rate through careful use of single embryo transfer in our good-prognosis patients.

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The take-home message is that cumulative live birth rates should be the way we report success of IVF. Creating Families: What can you do about the multiple births associated with intrauterine inseminations? Jason Min: This is potentially a big problem because we do not have good data on ovarian stimulation/IUI outcomes in Canada. Some authorities suggest that non-IVF fertility treatments may be responsible for more multiples than IVF. Unlike IVF, which is performed by specialists in IVF clinics where outcomes can be tracked, inseminations may be performed by doctors with little or no formal fertility training or experience, in office settings outside IVF clinics. In such cases, outcomes are

often not tracked carefully, if at all. Also, any physician can prescribe Clomid or other oral medications used to stimulate ovulation. These medications are also responsible for multiples, but I doubt anyone collects outcome data. We all have patients for whom we prescribed Clomid that we’ve never seen again. Keeping track of outcomes after inseminations would probably be very costly, adding to the challenge. Creating Families: Would you say that the trend in Canada with respect to the rates of multiple births in encouraging?

Jason Min: Overall I think we should be quite proud of how professionals in the fertility field have been promoting single embryo transfer in Canada. The practice guidelines of the Canadian Fertility and Andrology Society emphasize the importance of single embryo transfer in younger women. The take-home message is that cumulative live birth rates should be the way we report success of IVF. It does change the perspective and it makes it easier to convince patients and physicians alike that this is the way to go. After all, a healthy baby is the final goal of any fertility treatment, isn’t it? About Dr. Min

Dr. Jason Min is a physician and partner at the Regional Fertility Program in Calgary and a Clinical Assistant Professor of Obstetrics and Gynecology at the University of Calgary. He is active in the Canadian Fertility and Andrology Society, currently serving on the board of directors and as chair of the Clinical Practice Guideline committee. Dr. Min has been an invited speaker at both national and international meetings and conferences. He has published scholarly articles and clinical practice guidelines in peer-reviewed journals. His practice includes all areas of reproductive care, with particular interest in in vitro fertilization, male infertility and quality assurance in assisted reproduction.

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Fertility law is an ever-evolving and dynamic area of the law despite the stagnancy of the Assisted Human Reproduction Act,1 the main statute governing fertility law in Canada. Social changes and advances in technology are the driving forces behind the evolution of the law. Over the past ten years or so many important changes have occurred. In recognition and celebration of ten years of Creating Families, here is my top five list of important changes in the fertility law landscape in Canada.

The Assisted Human Reproduction Act (“AHRA”) came into force

A Legal Overview Highlights of the Past Decade by Sara Cohen, LL.B., founder of Fertility Law Canada in Toronto

Probably the most important on this list. One can’t really have a conversation about fertility law in Canada without using the Assisted Human Reproduction Act as a starting point. This piece of federal legislation came into force in April 2004, but is the result of a political process that began in the late 1980s. The AHRA is famous (or infamous, depending on your perspective) for criminalizing both commercialized gamete donation and commercialized surrogacy across Canada, as well as for criminalizing the payment of consideration to a person for “arranging the services of a surrogate mother” (such prohibited activities are punishable by up to ten years in jail and/or a $500,000 fine). The AHRA groups together diverse and arguably morally unequal offences, such as creating a chimera, cloning a human being, and purchasing sperm from a sperm donor, making them all punishable by up to ten years in jail and/or a $500,000 fine. The AHRA does clarify, though, that altruistic surrogacy and altruistic gamete and embryo donation are legal in Canada. Originally, the AHRA required licensing and regulation of many activities, and contemplated the existence of a national registry. Some of these provisions were struck by the Supreme Court of Canada (see #2 below). Further, although the AHRA was supposed to be supplemented by regulation in order to illuminate and provide direction with

The AHRA is famous (or infamous, depending on your perspective) for criminalizing commercialized gamete donation and commercialized surrogacy across Canada, as well as for criminalizing the payment to a person for “arranging the services of a surrogate mother”.

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the act, arguing that the Federal government was infringing on its jurisdiction by legislating health issues. In a complicated 4-4-1 split decision, the Supreme Court of Canada found in favour of Quebec, agreeing that various sections of the AHRA were ultra vires (outside of its jurisdiction) and therefore unconstitutional. Many of the impugned sections were struck, leaving gaping holes in the Federal legislation that for the most part have not been filled by provincial law. Notably, however, Quebec did not challenge the constitutionality of the criminal prohibitions of the AHRA and those remain in full force and effect.

respect to how to comply with the legislation, thus far, the 2007 Section 8 (Consent) Regulations are the only regulations that have been provided. These regulations are unwieldy and confusing, with fifteen pages of legalese used to set out the requirements necessary to use a gamete to create an embryo, use an embryo and retrieve a gamete posthumously. The lack of enforcement of the AHRA has in turn been criticized and commended (see #3 below). To this day, no charges have ever been laid against parents or doctors for an alleged breach of the AHRA. Further, when the AHRA came into force, it was contemplated that the legislation would be reviewed every three years. This hasn’t yet happened, even once.

The First (and Only) Charge Under the AHRA As of the time that I am writing this article, there has only been one set of charges laid under the AHRA since its inception in 2004. Twenty-seven charges were laid in March of 2013 against a Canadian fertility agent. In December of 2013, the agent pled guilty to purchasing ova from a donor, paying a woman for surrogacy services, and accepting consideration for arranging the services of a surrogate mother, in contravention of the AHRA. After a guilty plea, the agent was fined $60,000 but given no jail time (despite the fact that for each prohibited activity under the AHRA, a penalty of up to ten years in jail and/or a $500,000 fine was available).

Despite the “minimal” sentence, the investigation and charge was very significant for Canada’s fertility community, as these were the first and only charges ever laid under the AHRA, and the first time a Canadian court had involvement with enforcing the AHRA.

Because a plea bargain was struck, the court made no findings under the AHRA, and we continue to have no caselaw regarding the enforcement of the AHRA or the extent of the criminal prohibitions in the legislation. However, in order for a guilty plea to be accepted, the court has to determine that the elements of the crime were met and therefore, we can infer certain lessons with respect to the prohibitions on the purchase of ova from a donor, paying a surrogate mother for her services, and perhaps most notably, the payment and acceptance of consideration to arrange the services of a surrogate mother. A detailed analysis of this case is beyond the scope of this brief article.

Olivia Pratten’s push to ban donor anonymity in Canada is unsuccessful at the Supreme Court of Canada. Olivia Pratten is a Canadian woman conceived in the early 1980s through the use of anonymously donated sperm. She sued the Province of British Columbia (and others) for

Helping to build families across Canada and beyond.

Supreme Court of Canada Reference re Assisted Human Reproduction Act In December 2010, the Supreme Court of Canada released its long-awaited decision in the Reference re Assisted Human Reproduction Act. After the AHRA came into force, the Province of Quebec had brought a constitutional challenge to much of

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Extensive experience experience in surrogacyy, legal parentage, and egg, sperm and embryo donation.

Sara R. Cohen, lawyer Tel/Fax: 416.907.2189 sara@fertilitylawcanada.com www.ferrtilitylawcanada.com

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to the child, and it is not in the best interests of donor offspring”. She largely agreed with Ms. Pratten’s position, finding that donorconceived adults are discriminated against as compared to adult adoptees, and that Ms. Pratten’s section 15 (1) Charter of Rights and Freedom Olivia Pratten sued the Province of British rights had been violated by B.C.’s Columbia (and others) for allegedly unconstitutionally discriminating against donor-conceived underinclusive adoption legislation2. adults, as compared with adult adoptees. For a period of time, anonymous donaallegedly discriminating against donortions were banned in B.C. However, the B.C. conceived adults, as compared with adult Court of Appeal later unanimously overadoptees, by failing to take the necessary steps turned this decision, holding that a breach of to ensure that identifying personal and medMs. Pratten’s s. 15(1) Charter rights is ical information about gamete donors would permissible under s. 15(2) (affirmative be available to donor-conceived adults. Ms. action). Further, Ms. Pratten’s section 7 rights Pratten alleged that donor-conceived people were not violated, and the remedy sought by suffered from various traumas as a result of a Ms. Pratten is “…far more extensive” than lack of access to such information. This any person, including non-donor offspring, allegation was accepted as proven by the are entitled to; there is no legal entitlement to lower court. Madam Justice Adair of the know one’s past3. British Columbia Supreme Court noted that “…based on the whole of the evidence … Subsequently, Ms. Pratten sought leave to using an anonymous gamete donor is harmful

appeal to the Supreme Court of Canada while the entire Canadian fertility community held its collective breath. After a long and dramatic battle through the court system, Olivia Pratten’s case against the Province of British Columbia (and others) came to an end when the Supreme Court of Canada denied Ms. Pratten’s application for leave to appeal. Accordingly, it continues to be permissible to use anonymously donated gametes in Canada.

British Columbia and Alberta update their respective Family Law Statutes to include legal Parentage of children born through Assisted Reproductive Technologies. From a practical perspective, the most important recent updates to fertility law in Canada affect legal parentage of children born through ARTs. Both British Columbia4 and Alberta5 amended their respective family law statutes to consider and address legal parentage of such children. Similar legislation continues to be a rarity across the country with very limited exceptions. Despite this, it should be noted that Canadian intended parents have, for the most part, been incredibly fortunate in the surprising dearth of contested parentage of children born through ARTs. Since March 2013 (when its new family law legislation came into effect), British Columbia has had the most progressive legislation of any province nationwide with respect to the parentage of children born through surrogacy. This legislation reduces the need to bring an application for legal parentage before the court in most situations. Where: (i) the intended parents and a surrogate (traditional or a gestational carrier) enter into an agreement before the child’s conception, (ii) no one withdraws from the agreement, (iii) after the child’s birth the surrogate or gestational carrier provides written consent to surrender

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are helpful when it comes to determining who has parental rights and obligations to a child conceived through gamete donation. Both statutes specifically state that a donor is not a parent simply by virtue of the donation. With few exceptions, most other provinces’ legislation does not speak directly to parentage via gamete or embryo donation and accordingly there remain significant concerns about whether a donor may have parental rights to a child born in these jurisdictions.

Where is Fertility Law in Canada going?

the child to the intended parents, and (iv) the intended parents take the child into their custody, the intended parents are the legal parents of the child without the necessity of a court application6. Interestingly, the legislation considers and provides guidance to some atypical but important situations, including obtaining the consent of the surrogate if she cannot be located, is deceased or is not capable of giving consent, as well as legal parentage of a child born through the use of ARTs after the intended parents are deceased. Alberta’s legislation does not go as far as the B.C. legislation when it comes to parentage via surrogacy. Similar to the rest of Canada, the assumption in Alberta continues to be that a gestational carrier or surrogate is the mother of a child, and court involvement is necessary for intended parents to obtain legal parentage of the child. Further, unlike the B.C. legislation and Ontario caselaw, Alberta legislation requires that at least one parent have a genetic relationship to the child in order for the intended parents to obtain legal parentage of the child. However, both Alberta and British Columbia’s respective new family law statutes

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While I do not have a crystal ball looking into the future, we can hypothesize some changes that we anticipate will develop over the next couple of years. These changes will continue to be influenced by technological advances and societal changes. For example, now that technology has advanced to allow for egg banks, we anticipate the development of regulations around the importation and quarantining of donor ova into Canada. When provinces other than British Columbia and Alberta amend their family law legislation, we hope that the legal parentage of children born through assisted reproductive technologies will be taken into account. While no regulations to the Assisted Human Reproduction Act have been provided for the past eight years, and no review of the legislation has ever occurred, there is a feeling that something

must happen to this stagnant legislation. References: 1. S.C. 2004, c. 2 2. 2011 BCSC 656. 3. 2012 BCCA 480. 4. Family Law Act, SBC 2011, c.25. 5. Family Law Act, SA, 2003, c. F-4.5. 6. Supra note 2 at s. 29. 7. Supra note 2 at s. 24 and supra note 3 at s. 7.

About the Author Sara R. Cohen, LL.B. is a fertility law lawyer based in Toronto, but with clients throughout Canada and beyond. Sara is the founder of Fertility Law Canada and a partner at D2Law LLP where her practice is exclusively devoted to fertility law. She approaches fertility law with the compassion, empathy and respect it deserves. Sara is an adjunct professor of law at Osgoode Hall Law School where she teaches reproductive law, an elected fellow of the American Academy of Assisted Reproductive Attorneys (AAARTA), as well as the only Canadian representative on the Executive Council of the American Bar Association's Family Law Section, ART Committee. She is the Legal Co-Chair of the Ethics and Law Special Interest Group of the Canadian Fertility and Andrology Society (CFAS), and the legal representative on the Ethics Committee at Lifequest Centre for Reproductive Medicine, one of the largest and most well-respected fertility clinics in Canada. Sara was the co-chair of the first national conference on fertility law in Canada. Sara is also a long term Director of Canadian Friends of Haifa University. www.fertilitylawcanada.com