Authors: N.Rechberg, B.Kratochivl
Title: Daysy Literature Review
Language: English
Date: June 2014
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Daysy%Literature% Review
Valley!Electronics!AG Marienstrasse!16 CH 8003!Zurich Switzerland www.valley electronics.ch info@valley electronics.ch
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Company Function Valley!Electronics!AG QM
Company Name Function Date Signature Valley! Electronics!AG
Distribution&List
List&of&Review&/&Approval
Change&History
N.!Rechberg CEO Valley! Electronics!AG B.!Kratochvil CTO
Reviewer
Date Edition Author Modifications Pages 0.01 Natalie!Rechberg! First!draft!of!document All 0.02 B.!Kratochvil Minor!wording!updates All 1.00 B.!Kratochvil Added!Wikipedia!Excerpt.! Released 1.01 B.!Kratochvil Updated!methodology,!and! slight!improvements! throughout. All 1.02 B.!Kratochvil Small!updates!to!formatting. All 2.00 B.!Kratochvil Released All
3. Alternate,Therapies
There!are!a!wide!variety!(>20)!of!Apps!and!software!tools!for!tracking!a! woman’s!menstrual!cycle.!!The!ones!found!to!be!most!relevant!were:
• ClearBlue!from!Swiss!Precision!Diagnostics!GmbH!uses!urinary! measurements!to!track!ovulation.
This!literature!survey is!executed in!the!scope!of!the!clinical!evaluation!of!Daysy,! which!is!a!fertility!monitoring!device!which!is based!upon!LadyComp,!! BabyComp,!and!Pearly fertility!computers.!!The!devices!LadyComp!and! BabyComp!have!been!commercially!available!since!1986,!and!the!core!algorithm! and!method!have!been!used!in!the development!of!Daysy.
This!literature!survey!compares!a!number!of!different!fertility!awareness! methods,!with!a!goal!of!assessing!the!efficacy!of!temperature based!methods!in! comparison!of!their!peer!methods with!regards!to!both!conception!and! contraception.
• LadyComp,!BabyComp,!Pearly!from!Valley!Electronics!GmbH uses!daily!oral! BBT!measurements.
• Bioself!from!Bioself!Inc!uses!daily!oral!BBT!measurements.!!No!longer!in! operation.
• Cyclotest!2!from!UEBE!Medical!GmbH uses!daily!oral!BBT!measurements.
3.1. Devices
3.2. Apps
• Fertility!Friends • Glow • Clue • Kindara!Fertilty!Tracker • Ovia!Fertility
1. Introduction
The!following!devices!use!relevant!methods:
There!are!a!variety!of!fertility!awareness based!methods,!and!not!all!of!them! have!published!clinical!results.!!The!following!is!a!list!of!known!commercial!tools! used!to!assist!in!fertility!awareness based!family!planning.
Fertility!awareness based!methods’!of!family!planning!“involve!identification!of! the!fertile!days!of the!menstrual!cycle,!whether!by!observing!fertility!signs!such! as!cervical!secretions!and!basal!body!temperature,!or!by!monitoring!cycle!days.! Fertility!awarenessQbased!methods!can!be!used!in!combination!with!abstinence! or!barrier!methods!during!the!fertile!time”![WHO!2000,!Grimes!2012]
2. Objectives
• DuoFertility!from!Cambridge!Temperature!Concepts!Limited uses!a! measurement!sensor!continuously!attached!to!the!user.
• Cyclebeads!from!Cycle!Technologies uses!a!set!of!beads!to!assist!users!in! performing!a!calendar!based!method.
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In!addition,!data!was!gathered!from!archives!at!Valley!Electronics!GmbH which has!been!assembled! over!years!of!designing,!manufacturing,!and!supporting!the! LadyComp,!BabyComp,!and!Pearly!devices.!!This!information!comes!from! multiple!sources!such!as!contact!with!relevant!experts,!assembled!product! literature, and!periodic!searches.!!
4. Search,Methods
7.1. Biological!Background
7. Main,Results
The!fertility!awareness!methods!are!based!upon!the!fact!that!sperm!can!live!for!a! finite!amount!of!time!in!the!female!body.!!Therefore,!for!up!to!8!days![Raith!1994,! Wilcox!1998]!around!the!day!of!ovulation!there!is!a!statistical!probability!of! conception.!!Fertility!awareness!methods!use!a!variety!of!ways!to!track!this! window!and!users!are!then!able!to!choose!their!actions!based!on!the!desired! results.!!In!the!case!of!a!desired!pregnancy,!this!means!increased!sexual!activity.!! In!the!case!of!not!wishing!to!conceive,!they!must!employ!a!means!of! contraception,!such!as!a!barrier!method,!or!avoid!sexual!intercourse.
All!titles!and!abstracts!that!met!the!search!parameters!were!assessed!for! inclusion.!!The!studies!were!examined!for!the!methodological!quality,!potential! biases,!randomized!method,!and!discontinuation!rates.!!Although!a!number!of! studies!have!been!performed,!they!have!not!been!completed!in!systematic!and! methodological!enough!way!such!that!a!deep!statistical!comparison!between! methods!can!be!performed.
Searches!were!performed!through!ClinicalTrials.gov,!the!Cochrane!Library,! PubMed,!Google!Scholar,!and!other!online!search!mechanisms!concluding!on! 2014 04 13.!!This!search!included!terms!such!as,!but!not!limited!to:!fertility! monitor,!fertility!awareness,!BBT,!ovulation!prediction,!cycle!tracker,!and! LadyComp.
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5. Selection,Criteria
All!results!were!included!in!English!or!German!that!related!to!the!comparison!or! efficacy!of!temperature!based!fertility!methods.!!In!addition,!articles!addressing! the!efficacy!of!fertility!awareness!methods!in!general!were!added!such!that!a! comparison!between!different!methods!in!the!fertility!awareness!family!could!be! generated.
6. Data,Collection,and,Analysis
o Temperature+Method The!basal!body!temperature!(BBT)!is!the! lowest!temperature!taken!on!morning!wakening.!Following! ovulation,!rising!levels!of!progesterone!will!raise!the!basal!body! temperature!by!between!0.2!Q 0.5!degrees!Celsius,!which!indicates! ovulation!is!over.!The!temperature!will!remain!elevated!until!the! next!period.
Figure!1:!!The!probability!of!clinical!pregnancy!following!intercourse!on!a!given! day!relative!to!ovulation.![Wilcox!1998]
The!following!fertility!awareness!methods!have!been!identified.!!A!large!portion! of!the!summary!text!below!is!from![Family!Planning!NSW].
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o Rhythm+Method Select!the!shortest!and!longest!cycle!lengths,! subtract!21!from!the!shortest!cycle!and!subtract!10!from!the! longest!cycle.
7.2. Fertility!Awareness!Methods
• Calendar Based+Methods These!methods!involve!tracking!the!statistics!of! a!user’s!monthly!cycle.
o Hormonal+Methods+ These!methods!detect!changes!in!luteinizing! hormone!and!estrogen!(key!fertility!hormones),!to!typically! identify!6!fertile!days!per!cycle.
o Cervical+Mucus+Method+(Including+Billings+Ovulation+Method) This! method!involves!the!observation!of!the!variations!in!cervical! mucus!secretions!found!at!the!vaginal!opening.!This!can!be!used!to! identify!fertile!days!because!the!hormone!changes!through!a! woman’s!cycle!affect!the!consistency!of!these!secretions!felt!at!the! vaginal!opening.
o Standard+Days+Method This!is!a!simpler!version!of!the!calendar! method!and!should!not!be!used!for!a!woman!who!has!recorded! two!cycles!outside!the!range!of!26 32!days!in!any!one!year. First! fertile!day!is!day!8;!last!fertile!day!is!day!19. There!should!be!no! unprotected!sex!between!and!including!days!8!and!19.
• Symptoms Based+Methods Symptoms based!methods!involve!identifying! one!or!more!signs!of!fertility!using!the!basal!body!temperature,!cervical! mucus!secretions!or!cervical!changes.
When!evaluating!the!effectiveness!of!a!fertility!awareness!method!as!a! conception!aid,!the!amount!of!time!from!when!the!user!decided!to!conceive!to! the!time!where!they!actually!did!conceive!is!the!most!pertinent!metric.
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Two!studies!showed!that!the!fertility!rates,!are!perhaps!higher!than!previously! expected.!!In![Wang!2003],!the!authors!found!that!~50%!became!clinically! pregnant!in!the!first!2!cycles!and!>!90%!in!the!first!6!cycles.!!In![Gnoth!2003],!the! authors!analyze!the!time!to!conception!using!fertility!awareness!techniques,!and! find!that!for!fertile!women!using!fertility!awareness!methods!the!estimated! cumulative!probability!of!conception!at!1,!3,!6,!and!12!cycles!was!38,!68,!81,!and! 92%,!and!that for!couples!unable!to!conceive within!the!first!12!months,!but!with! a!reasonably!good!prognosis!(unexplained!fertility),!infertility!treatments!do!not! significantly!improve!the!chances!for!conceiving.!! In![Bachhofer!1997]!
A!number!of!studies!such!as![Raith!1994,!Wilcox!1995,!Wilcox!1998]!have!shown! that!nearly!all!pregnancies!can!be!attributed!to!intercourse!during!a!six day! period!ending!on!the!day!of!ovulation.!!The!timing!of!sexual!intercourse!in! relation!to!ovulation!has!no!influence!on!the!sex!of!the!baby.!!In!addition,!articles! such!as![Blake!1997]!have!shown!that!up!to!50%!have!an!adequate! understanding!of!when!the!fertile!time!occurred!in!their!menstrual!cycle.!!
7.3. Intended!Use! Conception!Aid
o Symptothermal+Method This!method!uses!observation!of!a! combination!of!two!or!more!signs!of!fertility!including! temperature,!cervical!mucus!secretions!and!changes!in!the!cervix,! to!calculate!fertile!times!of!the!cycle.
As!discussed!in![Lenton!1977],!traditional!BBT!are!not!very!effective!in! predicting!the!ovulation!window!for!aid!in!conception.!!This!is!because!the! method!is!only!able!to!estimate!the!ovulation!date!after!the!fact.!!The!technology! in!LadyComp,!BabyComp,!Pearly,!and!Daysy!uses!statistical!methods!based!on! the!previous!cycles!to!provide!a!prognosis!of!the!ovulation!data!upon!which!the! users!can!act.!!It!then!compares!the!predicted!date!to!the!measured!ovulation! date!at!the!end!of!a!cycle!to!update!its!model.!!Therefore,!these!devices!can! provide!relevant!data!to!be!used!for!improving!the!chances!of!successful! conception.
It!has!additionally!been!shown!by![Boivin!2007],!that!the!percentage!of!couples! seeking!medical!care!due!to!infertility!was!56%,!while!the!prevalence!of! infertility!(of!12!months)!was!around!9%.! This!coupled!with!the!previously! mentioned!facts!that!almost!all!conception!happens!within!a!6 day!window!and! up!to!half!of!women!do!not!understand!this!(or!when!the!window!is)!indicates! that!both!education!and!methods!are!needed!to!assist!with!couples!wanting!to! conceive.
• Lactational!Amenorrhoea!Method!(LAM) LAM!is!the!use!of!breastfeeding! as!a!contraceptive!method.!Breastfeeding!has!an!effect!on!the!production! of!hormones!that!reduces!the!probability!of!ovulation,!which!reduces!the! chance!of!pregnancy
Typical&Use&(Usage&safety) of!a!family!planning!method!takes!into!account!all! unintended!pregnancies!that!occur!in!all!months!(cycles)!of!the!study.
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7.4. Intended!Use!– Pregnancy!Avoidance
LadyComp/BabyComp!was!used!to!achieve!pregnancy!in!81!of!the!106!test! candidates.!!In!this!study,!the!average!time!to!conception!was!4.5!months. Due!to!a!lack!of!a!control!groups in!the!previous!studies,!no!strong!claims!can!be! made!as!to!the!efficacy!of!fertility!awareness!methods!as!opposed!to!couples!that! do!not!use!this!method.
When!evaluating!a!method!of!contraception,!it!is!useful!to!differentiate!between! the!effectiveness as!follows.
The!following!chart!shows!a!comparison!of!a!variety!of!different!methods for! avoiding!pregnancy.!!The!percentages!shown!in!the!column!are!the!percentage!of! women!that!get!pregnant!in!a!year!using!the!given!method,!which!is!sometimes! referred!to!as!the!Pearl!Index.
Perfect&Use&(Method&safety),!in!comparison,!takes!into!account!only!those! unintended!pregnancies!that!occur!despite!correct!usage:!abstinence!of!sexual! intercourse!during!the!fertile!days!(“red”!displayed!on!the!fertility!monitor)!and! during!the!learning!phase!(“yellow”!displayed!on!the!fertility!monitor).
Method Brand/Common& Name Typical&Use& (Usage&Safety) Perfect&Use& (Method& Safety) Vasectomy1 male!sterilization 0.15 0.10 IUD!with! Progestogen1 Mirena 0.2 0.2 IUD!with!Copper1 ParaGard,!Copper!T,! the!coil 0.8 0.6 BBT3 LadyComp 3.8 0.7 BBT4 LadyComp 5.3 n/a Oral!Contraceptive! Pill1 the!pill 9 0.3 NuvaRing1 the!ring 9 0.3 Diaphragm!and! Spermicide1 12 6 Symptothermal! Method2 13 20 2
[Robinson!2007]!performed!a!similar!study!with!Clearblue!Easy!Fertility!monitor! used!to!select!the!fertility!window,!but!with!a!control!group.!!This!study!found! that!the!cumulative!pregnancy!rate!for!2!cycles!was!higher!(22.7%!vs!14.4%),! and!although!the!location!for!identifying!the!fertile!window!is!different,! luteinizing!hormones,!the!results!are!relevant!to!the!other!fertility!awareness! methods. [Robinson!2007a]!also!estimated!that!mistiming!of!the!fertility! window!was!a!primary!cause!for!the!failure!to!conceive.! This!is!further! supported!by!the!work!of![Fehring!2014]
7.5.2. Monitoring,of,ovulation,by,sophisticated,digital,electronic,BBT,recording, „Babycomp“,in,patients,with,unexplained infertility.,,[Dessole(1997] The!study!was!conducted!by!the!University!of!Sassari,!Italy,!whereby!two! methods!for!the!prediction!and!detection!of!ovulation!and!for!the!diagnosis!of! luteal!deficiency!were!compared!and!analyzed.!The!study!was!performed!on!10! women!who!were!detected!as!being!infertile!for!the!last!three!to!eight!years.!The! women!were!followed!ambulatorialy!and!3!cycles!were!observed!and! documented.!In!total,!30!cycles!were!assessed.!
3!data!from![Bachhofer!1997]
Table!1:!Comparison!of!different!methods!of!avoiding!pregnancy.
2!data!from![Hatcher!2007]
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4!data!from![Freundl!1998]
Ovulation!Method2 22 3 Male!latex!Condom1 condom 21 5 No!Method1 85 85
1 data!from![Trussell!2011]
7.5. LadyComp/BabyComp/Pearly Detailed!Literature!Discussion
7.5.1. LadyComp,as,an,aid,in,natural,family,planning.,[Freundl(1992] In!15!cycles!the!time!of!ovulation!was!estimated!using!urinary!LH!measurements! and!ultrasound!monitoring!of!maximum!follicular!diameter!as!reference! methods!to!detect!the!ovulation.!To!determine!the!fertile!phase,!the!time!period! of!a!cycle!day! 5!to!day!+1!from!ovulation!day!(day 0)!was!measured.!The! information!of!the!LadyComp!was!compared!with!the!fertile!period!determined! by!the!reference!methods.
Within!the!15!cycles!(cycle!length!between!25!and!35!days)!the!average!duration! of!the!fertile!period!was!11.1!±!3!days!(min!9!days,!max!19!days).!A!temperature! shift!was!found!in!each!cycle.!In!8!cycles!(53.3%)!it!showed!the!beginning!of!the! fertile!time!on!day! 5!to! 7,!in!4!cycles!on!day! 8!or! 9,!and!in!3!cycles!prior!to!day! 9!(ovulation!=!day!0).!It!recognized!the!end!of!the!fertile!time!in!8!(53.3%)!cases! 24 48!hours!after!the!ovulation,!in!5!cases!3 5!days!later!and!in!2!cases!after! more!than!5!days!after!ovulation.
Compared!were!clinical!methods!of!measurement:!ultrasound, urinary!Luteal! Hormone!(LH)!testing!and!by!testing!the!progesterone!level!in!the!blood.!Of! those!30!evaluated,!26!cycles!!(86%)!were!ovulatory!and!4!were!not!ovulatory;!3! of!the!26!cycles!showed!an!LH!deficiency.!In!comparison,!the!BabyComp! evaluated!data were!24!cases!(80%)!ovulatory,!4!not!ovulatory!and!2!were!not! interpreted.!3!showed!an!LH!deficiency.!All!patients!determined!the!device!as! easy!to!use!and!less!complex!than!the!traditional!temperature!recording.! Moreover!it!was!concluded!that!the!device!can!be!used!for!further!detection!of! valuable!information.!!
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7.5.3. The,retrospective,study,of,the,reliability,,acceptance,and,safety.,[Bachhofer( 1997]
Over!a!period!of!more!than!two!years,!686!users!in!Germany,!Switzerland!and! Mexico!were!questioned!about!their!experiences!with!LadyComp/BabyComp.!It! was!ensured!that!women!in!those!countries!were!chosen!from!diverse income! ranges!and!occupations.!The!questioned!users!were!not!previously!educated!on! the!method!of!basal!body!temperature!or!its!physiological!background!nor!the! usage!of!a!fertility!monitor.!The!average!time!of!use!was!16!months.!!686! answered!questionnaires!were!available,!taking!into!account!10975!menstrual! cycles!of!use.!633!women!during!10601!months!used!BabyComp/LadyComp!for! pregnancy!prevention.!569!women!(83%)!of!those!questioned!used!the!devices! solely!for!pregnancy!prevention.!46!women!used!the!device!solely!for!pregnancy! planning:!71!women!(10.3%)!used!the!device!to!prevent!and!then!for!pregnancy! planning.!
In!the!study,!39!unplanned!pregnancies!in!10601 measured!months!occurred;!of! those,!33!unplanned!pregnancies!occurred!in!Switzerland!and!Germany.!All!33! pregnancies!occurred!either!during!“red”!(fertile)!days!or!on!“green”!(infertile)! days.!This!results!in!a!usage!safety!pearl index!of!3.8!for!those!women.!
To!evaluate!the!method!safety,!only!those!women!can!be!taken!into!account!that! became!pregnant!on!the!“green”!(infertile)!days..!In!total,!6!pregnancies!during! 10275!months!of!use!occurred!with!which!a!method!safety!pearl index!of!0.7!can! be!derived.!
7.5.4. Retrospective,clinical,trial,of,contraceptive,effectiveness,of,the,electronic, fertility indicator,LadyComp/BabyComp.,,[Freundl(1998] In!this!retrospective!study!LadyComp!and!BabyComp!were!used!for!pregnancy! prevention.!The!following!publication!was!based!on!Bachhofer’s!finding!and! dissertation!(1997).!In!further!evaluation!the!cumulative!pregnancy!rate!was! evaluated!on!hands!of!the!Life!Analysis!Table.!!The!likelihood!of!an!unplanned! pregnancy!during!a!usage!period!of!one!year!was!estimated!to!be!5.3%!(0.053),! after!2!years!6.8%!(0.068)!and!after!3!years!8.2%!(0.082).!The!period!of!the! fertile!phase!averaged!14,3!+ 4,6!days.!The!consumer!acceptance!rate!was! defined!as!very!high.!Even!of!the!33!(unplanned)!pregnancies!21!women! continued!using!the!device.!
LadyComp!and!BabyComp!showed!in!106!cases!the!conception!optimum!that! was!used!by!100!couples!to!achieve!pregnancy.!In!81!cases!pregnancy!occurred.! The!average!period!of!application!was!4.5!months.!BabyComp’s!extra!functions! for!planning!a!pregnancy!and!the!gender!prediction!prognosis!was!used!by!19! cases!of!81!occurred!pregnancies.!In!another!9!cases,!the!probability!of! “Boy/Girl”!was!given!or!the!prognoses!was!inapplicable.!The!length!of!the!fertile! period,!which!LadyComp!and!BabyComp!displayed,!had!an!average!of!14.3!+ 4.6! days.!For!more!than!50%!of!users!the!length!of!the!fertile!phase!was!11!to!16! days.!The!average!cycle!length!was!29.2!+!5.4!days.!
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7.6.4. Clearblue,
7.6.2. Cyclotest,2
The!predecessor!model!of!Bioself!Plus!temperature!computer,!Bioself!110,!was! evaluated!in!a!study!including!131!women!of!which!1238!cycles!were!evaluated! [Drouin+1992,+Flynn+1991].!Thereby!a!user!safety!with!a!Pearl!Index of!23!and!a! method!safety!Pearl!Index of!2!was!evaluated.!The!safety!of!not!impacting!data!of! the!fertile!days!was!at!86%.!Indication!of!the!average!period!of!the!fertile!phase! varied!between!9 19!days.!For!the!model!Bisoself!Plus!no!evaluation!results!are! available.!
Unipath!Ltd,!manufacturer!of!Clearblue!researched!the!effect!using!the!Clearblue! Fertility!Monitor!has!on!pregnancy!rates!in!women!trying!to!conceive.!Findings! revealed!that!approximately!23%!of!women!who!took!part!in!the!research!using! the!Monitor became!pregnant!during!the!first!two!cycles!of!use,!compared!with! 14%!of!the!women!who!were!not!using!the!Monitor.!This!indicates!that!over!a! third!more!women!conceived!using!the!Clearblue!Easy!Fertility!Monitor.! Additionally,!product!feedback!was!overwhelmingly!positive!with!90%!of! participants!agreeing!that!the!Fertility!Monitor!was!easy!to!use![Robinson+2007]
The!predecessor!model!Cyclotest!2!Plus,!was!tested!prospectively!in!accordance! with!the!data!of!the!fertile!phase!in!69!cycles.!In!57!ovulatory!cycles!the! temperature increase!was!determined!and!found,!on!the!day!of!the!objective! ovulation!to!2!days.![Bremme+1992, Freundl+1992].
7.6. Other!Fertility!Awareness!Method!Detailed!Literature!Discussion
A!retrospective!cohort!study!was!performed!on!the!DuoFertility!(Cambridge! Temperature!Concepts!Ltd.,!Cambridge,!UK)!on!how!DuoFertility!can!assist! infertile!couples!in!achieving!natural!pregnancy.!242!couples!who!were! determined!as!being!qualified!were!selected.!DuoFertility!program!resulted!in!an! average!clinical!pregnancy!rate!of!39%!after!12!month!of!use!this!was!stated!to! be!significantly!higher!then!the!success!rate!of!average!in!vitro!fertilization! [Chausiaux 2011].
7.6.3. DuoFertility
7.6.1. Bioself,Plus
The!concept!of!natural!family!planning!is!based!on!observation!of!the!female! menstruation!cycle!and!some!statistical!properties!of!it.!Digital!fertility!monitors, like!Daysy, are!using!the!same!methods,!while!reducing!the!risk!of!wrongly! interpreting!data!(as!it!is!done!by!a!machine)!and!wrongly!reading!or!noting! measurement!results!(as!it!is!done!by!a!machine).!If!the!device!is!used!correctly,! its!level!safety!cannot!exceed!the!particular!value!of!the!natural!family!planning! applied!properly,!but!it!can!approach!it!closely. If!users!decide!to!have!sex! during!their!fertile!periods,!they!must!use!some!form!of!contraception!to!avoid! pregnancy.
The!literature!demonstrates!that!digital!fertility!monitors LadyComp,!BabyComp,! Pearly,!and!Daysy can!be!safely!and!effectively!used!as!aid!in!conception!and! pregnancy!prevention.!!
8. Adverse,Affects
In!the!case!of!using!fertility!awareness!methods!as!an!aid!to!conception,!a! number!of!studies!show!indications!that!the!fertility!awareness!methods!are! beneficial,!and!none!have!thus!far!indicated!any!harm.!!
As!noted!by!the![WHO!2009],!‘Women!with!conditions!which!make!pregnancy!an! unacceptable!risk!should!be!advised!that!fertility!awareness based!methods!for! pregnancy!prevention!may!not!be!appropriate!for!them!because!of!their! relativelyQhigher!typicalQuse!failure!rates.’ Digital!fertility!monitors are a!way!to! mitigate!the!risk!down!to!a!significantly!lower!level,!and!have!been!shown!to! approach!that!of!forms!of!contraception!such!as!the!pill!or!sterilization.
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9. Summary,
In all!methods!examined,!the!usage!safety has!been!much!lower!than!the!method! safety,!making!usability!aspects!very!important.
It&must&be¬ed,&that&an&unwanted&pregnancy&is¬&a&harm&arising&from& the&application&of&the&device.&It&is&a&risk&of&the&natural&family&planning&per& se.&Using&natural&family&planning&means&accepting&this&risk.
Of!the!risks!to!the!user!not!previously!mentioned!and!included!in!the!Daysy!risk! analysis!(61_Risk_Management_File),!which!include!choking,!injury!by!sharp! edges,!irritation!of!the!skin/mucosal,!contamination!of!mucus,!and!infection,!zero! incidents!have!been!reported!in!the!literature.
In!the!case!of!pregnancy!prevention,!the!incidence!of!unwanted!pregnancies!for! the!method!is!slightly!higher!0.6 0.7% in!12!months!than!hormonal! contraceptives!(i.e.!the!pill)!at!0.3%,!but!on!a!similar!scale.!!The!usage!safety!is! has!been!found!to!be!lower!than!with!the!pill!at!3.8%!versus!9%.!!
Digital!fertility!monitors!do!not!prevent!from!the!transmission!of!HIV!and!STDs.
An!international!survey!of!the!health!economics!of!IVF!and!ICSI.!!JA! Collins! Human!Reproduction!Update,!2002
[Collins!2002]
[Frank Hermann!2006]
[Frank Hermann!1998]
[Boivin!2007]
International!estimates!of!infertility!prevalence!and!treatment seeking:!potential!need!and!demand!for!infertility!medical!care.!!J! Boivin,!L!Bunting,!JA!Collins,!KG!Nygren! Human!reproduction,!2007.
Fertility!Awareness!Based!Methods!of!contraception!(FABMs),!Family! Planning!NSW,!May!2013.
[Flynn 1991]
Variability!in!the!phases!of!the!menstrual!cycle Fehring!RJ,!Schneider! M,!Raviele!K. J!Obstet!Gynecol!Neonatal!Nurs.!2006!May Jun;35(3):376 84.
[Drouin 1992]
[Fehring!2014]
[Bremme!1992]
Monitoring!of!ovulation!by!sophisticated!digital!electronic!BBT! recording!„BabyComp“!in!patients!with!unexplained!infertility Dessole!S,!Fadda!MC,!Rosas!N,!Scapinelli!A,!Inaudi!P,!Ambrosini!A.! Internat!Meeting!Infertility!and!Assisted!Reproductive!Technology!,! Sardinia!1997
[Blake!1997]
The!value!of!an!electronic!microcomputerized!basal!body!temperature! measurement!device!(Bioself)!in!in!vitro!fertilisation!cycles Drouin!J,! Guilbert!EE,!Desaulnier!G!et!al. Gynecol!Endocrin!!1992;!6:!283 286
Babycomp!as!an!aid!for!adoslescent!contraception.!Freundl!G,!Frank Hermann!P,!Toncaboni,!M.!Europ!Congress!Pediatric!Adolescent! Gynecology,!Rhodes!1988
Fertility!awareness!in!women!attending!a!fertility!clinic Blake!D,!Smith!D,!Bargiacchi!A,!France!M,!Gudex!G.!!The!Australian!and! New!Zealand!Journal!of!Obstetrics!&!Gynaecology,!1997
The!minicomputer!BabyComp/LadyComp!in!natural!family!planning DM!Bachhofer,!Dissertation!Medizin.!Fakultät!Heinrich Heine! Universität,!Düsseldorf!1997
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[Chausiaux 2011]
[Fehring!2006]
[Frank Hermann!1988]
Springer!Berlin,!Heidelberg,!New!York!!1994
Analysis!of!the!computer!thermometer!Cyclotest!D!to!be used!for! natural!family!planning Bremme!M,!Freundl!G,!Frank Hermann!P.! Advances!in!Contraception!!1992;!8:!221
10. References
Efficacy!of!achieving!pregnancy!with!fertility focused!intercourse. Mu!Q,!Fehring!RJ.!MCN!Am!J!Matern!Child!Nurs.!2014!Jan Feb;39(1):35 40.
The!effectiveness!of!a!fertility!awareness!based!method!to!avoid! pregnancy!in!relation!to!a!couple’s!sexual!behavior!during!the!fertile! time:!a!prospective!longitudinal!study Frank Hermann!P.,!Heil!J.,! Gnoth!C.,!Toeldo!E.,!Baur!S.,!Pyper!C.,!Jenetzky!E.,!Strowitzki!T.,!Freundl! G.,!Hedleberg,+2006
[Bachofer!1997]
Chausiaux,!Cambridge!Temperature!Concpets!Limited.! Pregnancy!Prognosis!in!infertile!couples!on!the!DuoFertility! Programme Compared!with!In!Vitro!Fertilization/!Intracytoplasmic! Sperm!Injection.!!O!Chausiaux,!J!Hayes,!C!Long,!S!Morris,!G!William,!S! Husheer,!European!Obstetrics!&!Gynecology,!2011;!6!(2):!92 4
An!evaluation!of!the!Bioself!110!electronic!fertility!indicator!as!a! contraceptive!aid.!!Flynn!A!,!Pulcrano!J,!Royston!P,!Spieler!J.! Contraception!!1991!4!125 139
Reference Citation
[Family!Planning!NSW]
Natural!Family!planning.!Freundl!G,!Frank Hermann!P,!Raith Paula!E.! Gynäkologe!!1998;!31:!398 409
[Dessole!1997]
[Polskie!2010]
The!reliability,!acceptability!and!applications!of!a!basal!body! temperature!(BBT)!records!in!the!diagnosis!and!treatment!of! infertility Martinez!AR,!Hooff!HA,!Schoute!E,!Meer!M,!Broekmans!FJM,! Hompes!PGA. Europ!J!Obstetric!& Gynecology!Reproductive!Biology!! 1992;!47:!121 127
Mistiming!of!intercourse!as!a!primary!cause!of!failure!to!conceive:! results!of!a!survey!on!use!of!a!home use!fertility!monitor. Robinson!JE,!Ellis!JE.!!Curr!Med!Res!Opin.!2007!Feb;23(2):301 6.
Natural!Family!Planning!Today,!Raith!E,!Frank!P,!Freundl!G. Springer!Berlin,!Heidelberg,!New!York!!1994
Increased!pregnancy!rate!with!use!of!the!Clearblue!Easy!Fertility! Monitor Robinson!JE,!Wakelin!M,!Ellis!JE.,!Fertil!Steril. 2007! Feb;87(2):329 34.!Epub!2006!Oct!30.
[Gnoth!2005]
Osteopathic!Family!Phsician,!Vol!5,!No!1,!January/February!2013.
[Hatcher!2007]
[Freundl!1992]
Timing+intercourse+to+achieve+pregnancy:!current+evidence Stanford)JB,) White&GL,&Hatasaka&H,&Obstet&Gynecol.&2002.
[Manhart 2013]
[Stanford!2002]
Temperature!for!the!evaluation!of!the!fertile!time!in!the!cycle!of!a! woman:!Babycomp,!Bioself!110,!Cyclotest!D.!Freundl!G,!Baur!S,! Bremme!M,!Döring!G,!Frank Hermann!P,!Godehardt,!Kunert!J. Fertilität!! 1992;!8:!66 76
Document!Name!/!Version Uncontrolled!Copy!w/o!Signature Released!/!Tested!/!Date!/!Sign Page!/!Page(s) 30_Literature_Review.docx /!2.00 12/05/14!12:40 14 /!15
[Gnoth!2003]
Problems!in!using!basal!body!temperature!recordings!in!an!infertility! clinic. Lenton!EA!,!Weston!GA!and!Cooke!ID! British!medical!journal,!1977
[Robinson!2007a]
Contraceptive!technology
Fertility!awareness based!methods!for!contraception David!A!Grimes,! Maria!F!Gallo!,!Vera!Halpern,!Kavita!Nanda!,!Kenneth!F!Schulz!and! Laureen!M!Lopez!
Polish!Gynecological!Society,!Recommendations!of!the!Polish! Gynecological!Expert!Panel!on!Natural!Family!Planning!methods!used! as!contraception,!Polskie!Towarzystwo!Ginekologiczne.! Listopad,!November!2010
[Frendl!1992]
[Robinson!2007]
[Freundl!2003]
Definition!and!prevalence!of!subfertility!and!infertility.!!Gnoth!C,! Godehardt!E,!Frank Herrmann!P,!Friol!K,!Tigges!J,!Freundl!G Hum! Reprod. 2005!May;20(5):1144 7.!Epub!2005!Mar!31.
[Martinez!1992]
[Grimes!2012]
[Lenton!1977]
Fertillity!awarenss based!methods!of!family!planning:!A!review!of! effectiveness!for!avoiding!pregnancy!using!SORT.!!Manhart!D.,!Duane! M.,!Lind!A.,!Sinai!I.,!Golden Tevald!J.
Online!Publication!Date:!October!2004,!updated!2012.
Ladycomp!as!an!aid!in!natural!planning.!!Freundl!G,!Baur!S,!Bremme!M,! Döring!G,!Frank Hermann!P.!!Advances!in!Contraception!!1992;!8:!184
[Freundl!1992]
Estimated!maximum!failure!rates!of!cycle!monitors!using!daily! conception!probabilities!in!the!menstrual!cycle. Freundl!G,!Godehardt! E.!Kern!P.A.,!Frank Hermann!P.,!Koubenec!H.J.,!Gnoth!CH.!Human! Reproductive!Vol.!18,!No.!12!pp.2628! 2633,!2003.
Time!to!pregnancy:!results!of!the!German!prospective!study!and! impact!on!the!management!of!infertility.!!C.!Gnoth,!D.!Godehardt,!E.! Godehardt,!P.!Frank Herrmann!and!G.!Freundl,!Human!Reproduction! Vol.18,!No.9!pp.!1959±1966,!2003.
Temperature!computer!for!the!evaluation!of!the!fertile!time!in!a! woman!cycle:!Babycomp,!Bioself!110,!Cyclotest!D. Freundl!G,!Baur!S,! Bremme!M,!Döring!G,!Frank Hermann!P,!Godehardt,!Kunert!J. Fertilität++ 1992;!8:!66 76
[Freundl!1998]
[Raith!1994]
RA!Hatcher,!J!Trussell,!AL!Nelson! 2007
Retrospective!clinical!trial!of!contraceptive!effectiveness!of!the! electronic!fertility!indicator!Ladycomp/Babycomp.!!Freundl!G,!Frank Hermann!P,!Godehardt,!Klemm!R,!Bachhofer!M. Advances!in!Contraception!!1998;!14:!97 108
Contraceptive!failure!in!the!United!States J!Trussell! Contraception,!2011! Elsevier
results!posted.
Relevant.!!Results!not! yet!posted.
Completed Efficacy!Study!of!the!OV Watch™!Personal! Fertility!Monitor!for!Women!Using! Clomiphene!Citrate.
Post ovulatory!ageing!of!the!human!oocyte!and!embryo!failure AJ!Wilcox,!CR!Weinberg,!DD!Baird! Human!Reproduction,!1998!
10.1.1. ClinicalTrials.gov
Completed Clearblue!Advanced!Fertility!Monitor! Consumer!One!Cycle!at!Home!Study
Not!Relevant.!!No!
Status Study
Medical!eligibility!criteria!for!contraceptive!use.!!Fourth!Edition,!A! WHO!Family!Planning!Cornerstone,!2009.
World!Health!Organization.!Improving access!to!quality!care!in!family! planning.!Medical!eligibility!criteria!for!contraceptive!use.!Second! Edition.!Geneva:!World!Health!Organization,!2000:FAB!1 4.
[Wilcox!1998]
[WHO!2009]
Relevant.!!Currently! running.
[WHO!2000]
Timing!of!sexual!intercourse!in!relation!to!ovulation effects!on!the! probability!of!conception,!survival!of!the!pregnancy,!and!sex!of!the! baby AJ!Wilcox,!CR!Weinberg,!DD!Baird! New!England!Journal!of! Medicine,!1995
LadyComp/BabyComp!and!Clearblue! Monitors
[Tan!2003]
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[Wilcox!1995]
Active,!not! recruiting Comparison!of!Two!Internet!Supported! Natural!Family!Planning!Methods
[Wang!2003]
Relevance Comparison!of!DuoFertility,! High.!!Status!of!study! unknown!after!further! searching!online.
Conception,!early!pregnancy!loss,!and!time!to!clinical!pregnancy:!a! population based!prospective!study Wang!X,!Chen!C,!Wang!L,!Chen!D,! Guang!W,!French!J,!Fertil!Steril. 2003!Mar;79(3):577 84.
[Trussell!2011]
The!most!recent!search!of!clinicaltrials.gov!was!performed!on!2014 04 13!with! the!following!search!terms:!fertility!monitor,!BBT,!ovulation!prediction,!cycle! tracker,!LadyComp
The!following!relevant!studies!were!found.!!Note:!!Some!studies!were!clearly! irrelevant!and!not!included!in!this!list!for!the!sake!of!brevity.
Unknown
Cumulative!conception!and!livebirth!rates!after!in vitro!fertilization.!! Tan!S.!L.,!Betts!J.,!Mason!B.,!Edwards!R.!G.,!Tan!S.!L.,!Campbell!S.,! Royston!P.,!Jacobs!H.!S.,!The!Lancet,!Volume!339,!Issue!8806,!6!June! 1992,!Pages!1390 1394