Techagappe 23rd Edition (April – June 2020) Ebook by Techagappe

Vol.5 Issue 3

APRIL - JUNE 2020

THE DIAGNOSTICS NEWS JOURNAL

Published at Agappe Diagnostics Limited on April 01, 2020 | 62 Pages | ` 20

AGAPPEâ&#x20AC;&#x2122;S TRAIL BLAZING SAGA OF MAKE IN INDIA INITIATIVE Mr. Thomas John

INFERTILITY AN OVERVIEW Prof. Dr. D M Vasudevan

ADDRESSING INFERTILITY WITH A HUMANE PASSION Dr. Kamini A. Rao

IN VITRO FERTILIZATION IN DEVELOPING COUNTRIES Dr. Gautam Allahbadia

DREAMS & DESPERATION INFERTILITY SPECIFIC DISTRESS Dr. Pratap Kumar Narayan

POLYCYSTIC OVARY SYNDROME CLINICAL GUIDELINES FOR FERTILITY Dr. Sonia Malik

INFERTILITY EXPLORING INFERTILITY DISORDERS FROM DIFFERENT ANGLES

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CONTENTS ○

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Volume 5 | Issue 3 | April-June 2020 ○

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Motherhood : Whole world in my arms

14-17 Infertility : Its not the end of the road 22-25 Addressing infertility with a humane passion : Interview 26-27 Ferritin: The most sensitive and specific marker of iron deficiency 28-31 In-vitro fertilization in developing & low resource countries

08-11

AGAPPE’S TRAIL BLAZING SAGA OF MAKE IN INDIA INITIATIVE

44-47 PCOS : Clinical guidelines for fertility 48-50 Infertility: A few tips for a contented marital life 52-53 All about the auxiliary solutions in automation 56-57 Engagements

18-21

AMAZING STORY OF INDIA’S FIRST TEST TUBE BABY

36-39 Pushpagiri Hospital : Epitome of quality healthcare 40-43 In cycles of Dreams & Desperation : A review on infertility specific distress

Testimonials

32-35

THE UNIQUE STORY OF AN IVF BORN WOMAN CONCEIVING NATURALLY

Views and opinions expressed in this magazine are not necessarily those of Agappe Diagnostics Limited, its publisher, or editors. We do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. We do not take responsibility for returning unsolicited material sent without due postal stamps for return postage. No part of this magazine can be reproduced without the prior written permission of the publisher. Techagappe publishers reserve the right to use the information published herein in any manner whatsoever. Caution: After going through the techniques, procedures, theories, and materials that are presented in Techagappe, you must make your own decisions about specific treatment for patients and exercise personal/professional judgment for further clinical testing or education and your own clinical expertise before trying to implement new procedures. Contact info: The Manager-Corporate Communication, Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O., Ernakulam district , Kerala-683 562, India. www.agappe.com Contact: Ph: + 91 484 2867065, Mob: +91 9349011309. Published from Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O., Ernakulam district , Kerala-683 562, India. Contact: Ph: + 91 484 2867000, Fax: + 91 484 2867222; Printed at Five Star Offset Printers, Nettoor, Cochin-40, for Agappe Diagnostics Limited Printed and Published by Ms. Meena Thomas on behalf of Agappe Diagnostics Limited and Printed at Five Star Offset Printers, Nettoor, Cochin-40 and published from Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O, Ernakulam district, Kerala-683 562. Editor is Ms. Meena Thomas.

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From The Chief Editor’s Desk

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THE DIAGNOSTICS NEWS JOURNAL

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years of its existence, I am happy to report that this magazine is being regularly published every 3 months. This edition covers various aspects of infertility. We have included three medical articles, two live stories and interviews with eminent personalities, one technical article and a few health tips. In the first article the MD of Agappe explains the Make in India initiative by introducing the Mispa CountX, the indigenously developed three-part haematology analyser. An additional article is also incorporated from the management of L&T Technology Services, our partner in this project.

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EXECUTIVE DIRECTORS Meena Thomas Sangeeta Joseph Mary Baby Meleth Prof. Dr.D M Vasudevan

I am proud to bring out this 23rd edition of TechAgappe. During the last 5

In the medical articles session, we have included three articles on infertility. The first one is from my desk, giving an overview on human infertility issues. The second article is on IVF in Developing Economies from Dr Gautam Nand Allahbadia who is the Medical Director and Consultant for Reproductive Endocrinology & IVF at Rotunda-The Centre For Human Reproduction, the world-renowned infertility clinic at Bandra, Mumbai, India. The third article is a review on Infertility Specific Distress by Dr Pratap Kumar Narayan, Professor and head, Department of Obstetrics & Gynaecology, Kasturba Medical College, Manipal. In the life story session, the first one is on Ms Kanupriya Agarwal from Kolkata, the first test tube baby in India. The article gives an insight into difficulties faced during the early period of test tube babies. The second story is on Ms Harsha Shah from Pune, the first IVF born woman who later became pregnant and delivered a baby, naturally. In addition, we have included two interviews to share their experiences of medical profession. First is with Dr. Kamini Rao from Bangalore, the prestigious Padmashree award winner for her renowned service in infertility treatment. The second interview is with Dr. Sonia Malik, who was the then president of Indian Fertility Society. She is discussing Good Clinical Practice for managing PCOS to prevent infertility. The third interview is with the management of the Pushpagiri hospital, Thiruvalla, Kerala, who are Agappe’s business partners for more than two decades.

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MANAGING DIRECTOR Thomas John

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CHAIRMAN Prof. M.Y. Yohannan

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BOARD OF DIRECTORS

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PHOTOGRAPHY Nelson Thomas

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DESIGN AND LAYOUT M T Gopalakrishnan Dezign Centre, Kochi.

EXPLORING INFERTILITY DISORDERS FROM DIFFERENT ANGLES...

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PUBLISHING COORDINATOR Jayesh Kumar

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LEGAL ADVISORY BOARD Adv. Denu Joseph

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EDITORIAL ADVISORY BOARD Rajesh M Patel Dr. C S Satheesh Kumar Abraham K C Varghese George Sanjaymon K R Sankar T S Bintu Lijo

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CONSULTING EDITOR Saj Mathews

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CHIEF EDITOR Prof. Dr. D M Vasudevan

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EDITOR Meena Thomas

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EDITORIAL BOARD

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Volume 5 | Issue 3| April - June 2020 ○

I am glad to state that we have received very good feedbacks and great appreciation letters for the previous issues, out of which, some selected letters are published in this edition. We thank all the readers for their continued support. Your constructive criticisms to improve the contents will be greatly appreciated. With warm personal regards and wishing a very happy new financial year.

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Subscription-For subscription queries, write to techagappe@ agappe.in or call us at +91 484 2867065. Permissions-For permissions to copy or reuse material from Techagappe, write to techagappe @agappe.in Letters to the editor-Email: techagappe@agappe.in Postal address: The Manager-Corporate Communication, Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O., Ernakulam district, Kerala-683 562, India. Advertisement QueriesEmail: techagappe@agappe.in

To empower the knowledge of IVD technicians, we have included a technical article on the auxiliary solutions in automation.

Dr. D.M. Vasudevan

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VOICE OF READERS

Exceptional in Lab Diagnostic Industry

Power of printing media is proven Hats off you dear Team Techagappe for such a wonderful magazine. In today’s life, so many medical advancements are happening. But the progress of medias by which news are getting circulated is not appreciable. Here comes the importance of Techagappe. We are very happy to realise that the power of printing media is proven when reding such a magazines where all type of people irrespective of their profession, gender and interest would be benefitted. You are requested to keep us in regular subscription list. Wish you all hearty blessings to continue this great mission. S. Sarkhel, Director, CINPS, Kolkata

Helpful for Ayurvedic Students We are very much impressed with your magazine ‘Techagappe’. Our ayurved ic students are very much eager to read its content. Through magazine is based on Allopathic medicines, the latest updates are clearly communicated in each and every edition which will be useful to approach diseases from Ayurvedic view.. Life story sessions are quiet interesting. Great Job Done by Agappe team. Good Luck. Shreya Das, Lecturer, Maria Ayurveda Med ical College, Kanyakumari.

TECHAGAPPE

Techagappe is exceptional in lab diagnostic industry. Being an administrator of a laboratory, we found it very useful to update our knowledge especially when it comes to technical articles which is coming under good laboratory practise. All the other stories are also good and worth to read. Most prominent feature of your magazine is discipline you keep in presenting all the content which is very appreciable. We would also like to inform you that our address has been recently changed, we are informing it for not to miss any valuable editions. K. K. Das, Amrita Laboratory, Coimbatore.

Business Deals with a Noble Mission Hats off to Team Techagappe, Very proud to declare that I am a regular reader of Techagappe news journal. By your latest edition, I have come to know that Agappe is celebrating their silver jubilee. We are

Impressive in Content Quality as well as Presentation Warm greetings! I am in receipt of your prestigious magazine TechAgappe at regular intervals and found it quite impressive and I am attracted to its fair presentation. Last edition provided a lot of helpful information and as a reader, I am very much honoured for having subscribed to such an informative magazine. Dr. Harish Shenoy, Lecturer in Pathology, Mangalore delighted to know your business deals which has a certain noble missions. Divine love is always precious and you ensure your words in quality and innovations. May god bless you all to serve the public. Regarding magazine, congrats to the entire team for your excellent presentations in all the way. Here asking you a support. I would like to know the methods/tests to confirm the presence of Mycobacterium leprae in wound discharges or tissue biopsy of non-healing ulcers or osteomyelitis bones or cutaneous

Splendid Life Stories and Awesome Articles I am receiving your magazine regularly and I am very happy to inform you that the life story session is great and the medical articles are awesome. Many persons get support and ample motivation from this journal. Hope you can continue with same spirit and quality. All the Best. Dr. S B Lal Mittal, Ex-National Vice President (IMA)

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nerves. This could enable me to proceed with treatment. Kindly guide me in this juncture and expecting an article about this topic in future editions. Thanks to you in advance. Dr.M.Pasupathi.,

M.Ch.,

Erode.

Salubrious Content in Lucid Language Very happy to receive your magazine. Since each edition is published with specific cover stories, it is easy to order book in our library and concerned departments can easily use its content for educating their students. Other articles like health tips and life stories are good and excellent parts of the magazine. It provides a charming effect to the analysing habits of readers. Nicely presented and lucid language is the essence of easy reading from an ordinary man’s view. The entire team deserves a sincere pat. Keep going with this great effort. Dr. Kamlesh Kumar Tanwani, J L N Hospital, Ajmer

Cover Story

Poem on Infertility

Expectancy in endlessness realms of infinite persistence & excitement, Conjecturing the new arrival of life in my womb, but all in vain, Yearning for dear Motherhood & fondness, a divine blessing, Paying price of PCOS, obesity & sedentary dispositions, Capsules, injects in plethora & lots procedures innards, As Confederates and chums gamboling with babes ecstatic, Barren desolate world, no rejoicing moments, me deeply afflicted. Against all odds of life, all logic, may I hope for the best to love new soul, It is so hard to see the rainbow, when rain continues days long unbroken, For a movement in my tummy and great life time in my whole heart, Prayers in every breath, treatment and Yoga, set my rhythms, Lord is gracious to me finally, beyond shadows, with new soul! Universe is with those, unceasingly seeking all remedies from Him.

Dr. Satheesh Kumar C.S Senior Vice President, Supply Chain Management, AGAPPE

How euphoric am to horse around with the sudden God-given arrival, Change of my life beyond words and my enchanted world indescribable, Motherhood is nothing but great acceptance, new horizon, new boundaries.

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AGAPPE MD’s Desk

AGAPPE’S TRAIL BLAZING SAGA OF

MAKE IN INDIA INITIATIVE Thomas John, Managing Director, AGAPPE

As we are crossing our Silver Jubilee Year, it is our pride as Agappeans to enlist some of the trailblazers in the field of Indian IVD market. Throughout these years Agappe has always tried to bridge the gap between High precision diagnostics tests and the rural population in India.

when we are crossing our Silver Jubilee Year with immense

pride, let us underline that our endeavor has always been break out of the standard norms of operations and focus more on developing instruments. We have developed a host of trailblazing instruments and systems with the sole intention of helping aspiring entrepreneurs to set up well equipped labs capable of carrying out the required diagnostics tests at the most remote locations in India. This has led us to design and create an array of intelligent breed of equipment including i-Series with the aim of bridging this gap.

albeit the margins continued to come from the 5-part analyzers. Today with rise in population and growing healthcare need, India needs 15,000-20,000 blood cell counter machines to serve both

Hematology The Indian hematology instruments and reagents market in 2018 was estimated as Rs 790 crore. Reagents constitute 63.3 percent of the market at Rs 500 crore, and instrument the balance at Rs 290 crore. Mispa CountX is India’s first indigenously built blood cell counter in partnership with L&T Technology Services (NSE: LTTS), a leading global pure-play engineering services company. The latest innovation from the AgappeLTTS alliance promises to revolutionize the diagnostics landscape in India particularly on the backdrop of the affordability aspect it enables. The hematology instrument market may be segmented as 5-part and 3-part analyzers. By quantity, in 2018, the 3-part analyzers dominated with an estimated 85 percent market share,

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Thomas John (Managing Director) and Meena Thomas (COO & Director) AGAPPE.

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urban and rural India, majority of these analyzers are imported from US, Japan, China and Europe. The cost of imported machines and consumables are high which directly or indirectly impact the patient spending.

Made in India Hematology Analyzer Agappe have designed a totally Made in India hematology analyzer with advanced technologies to support patient care, by delivering the right results at the most affordable cost. Foundational to the system its core technologies include smart impedance technology; the features offer cell counting and precise cellular assessment for excellent red blood cell, platelet and white blood cell. The CountX technologies are intended to help laboratories deliver quality results for fast, accurate clinical decision-making. At the same time, the system includes touch screen enabled system to streamline the number of procedural steps needed check flags and measure cell count thus offering predictable performance and greater laboratory efficiency.

Dr. Barnali Das and Dr. Helan Martin launching Mispa Label-Automatic Tube Labeling System at APFCB Conference, Jaipur.

The technology generates reportable results as quickly as 60 test / hr, reducing the time, supplies and costs that may be required for systems with higher repeat rates. Further, Mispa Count X features one of the smallest footprints and in its class, making it highly efficient in utilization of laboratory space. Many of the parameters available with CountX analyzer are designed to directly impact patient care by addressing critical conditions, such as thrombocytopenia, and anemia is another often-deadly condition that affects millions of people in India each year. Accurate Reliable Mispa CountX is a compact hematology system and provides 20 hematology parameters, with 3 Histogram. The CountX Smart technology requires micro-sampling of 14 µL of whole blood and 20 µL of prediluted to run any mode of blood sample. High-tech Laser cut Ruby aperture of 70 micron for RBC - Platelet and 100 Micron for WBC, The facets of brilliant cut gems Known for its strength and high precision is designed to offer better impedance and to offer interference free quality result.

The largest hematology reagent manufacturing capabilities Agappe also holds the position of the largest hematology reagent manufacturing capabilities in Asia Pacific with more than 20,000 Liter per batch. Mispa CountX reagent is designed to deliver most accurate results at most affordable cost per test which will be the lowest as compared to other analyzers in same segment. The CountX will provide a high level of continuity of care for clinical laboratories, regardless of whether they are small or high volume facilities, with CountX Agappe aims to 55,000-60,000 laboratories in India provide accurate diagnostics.

Pre-Analytics As in this Silver Jubilee we have stepped into the realm of Pre-Analytics. Since, the publication of ‘To Err is Human’, by the Institute of Medicines’, Committee on Quality of Health Care in America, the silence surrounding medical errors was broken and reducing medical errors became a priority for the whole world. In laboratories, every analytical method has some amount of error which can be monitored, controlled and the analytical process can be improved, thanks to Levey- Jennings and Westgard rules. But there are errors ‘out of the box’, if we investigate the pre-analytical phase, we see that every laboratory is unhappy in their own way. The problems tend to be unique, so are the solutions. The analytical phase has always witnessed advanced technology and improved automation. Digitization is the new trend in Indian In Vitro Diagnostics market. Hospitals and laboratories have started digitalization across the value chain with more focused approach to take care of pre-analytical errors. the largest component of variability lies in the pre-analytical phase with estimates suggesting that 60-75% of the total error may occur at this stage. Proper specimen labelling practices are critical components of effective and accurate patient identification. Accurate and timely labelling of specimens is an integral part of patient identification. It is critical because errors resulting from a failure in this step can, at best, provide results of no clinical value and, at worst, lead to the most adverse of patient outcomes. The new intelligent tube labelling system, Mispa Label de-

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AGAPPE MD’s Desk

Healthcare

tech-

nologies have continued to make rapid strides over the last decade, but affordable healthcare services are yet to reach the masses in developing nations, such as India. One of the key areas that need greater coverage is hematology and in particular,IVD owing to the high cost of the devices. Now, as such, high end equipment is fairly Bhupendra Bhate imported into and Chief Innovation Officer hence, very much L&T Technology Services Ltd. costly. The idea behind the Agappe-LTTS initiative was to make advanced healthcare affordable and accessible to all. It was important to understand the requirements, their inter-linkages, and complexities, and turn them into actionable design inputs. The plan was simple though – design a holistic yet compact blood analysis device that was affordable but didn’t compromise on quality.

LTTS – Agappe: Partners in affordable healthcare When Agappe, one of India’s major in-vitro diagnostics companies joined hands with LTTS, a leading engineering and technology company in the country to develop a state-of-art hematology device, the idea was to make advanced healthcare affordable and accessible to all. It was important to understand the requirements, their inter-linkages, and complexities, and turn them into actionable design inputs. The plan was simple though – design a holistic yet compact blood analysis device that was affordable but didn’t compromise on quality. After various rounds of deliberation, it was decided that for every micro litre of blood sampled, the device must categorize 4-7 million RBCs, 150-450 thousand platelets, and 4-11 thousand WBCs to be accounted for – all in less than a minute. The challenge was how to do this at uncompro mised levels of accuracy in measurement without being too expensive to impl ement. LTTS ide-ntified three key areas to address this challenge: Sourcing the right crystal: Hematology tests require the use of a crystal which contributes

It may be noted that the need of the hour is to design and develop in India, state-of-the-art hematology devices that are highly accurate and affordable. The whole idea is to reduce the capital cost of acquiring and installing such devices for rural healthcare centers, and thereby, extend standard hematology diagnostic services to those regions. signed and manufactured by Agappe Diagnostics Ltd., will help you get the barcodes straight on to the blood collection tubes. Mispa Label can label blood tubes and Urine tubes correctly and it ensures that you never go wrong with the A…B…C… of pre-analytics, which are Right Alignment, Right Barcode label and Right Collection tube. The right collection tube is selected automatically by the equipment through Intelligent Mechanical Drop (IMD) Technology. The patient identification data can be entered manually, through LIS or HIS or through external barcode reader and the equipment automatically generates the respective barcode and labels it on to the collection tube in the right alignment. Mispa Label is more secure as it works on Linux Operating System. With a throughput of 600 tube labels per hour, Mispa Label suits medium and high end sample workload laboratories delivering quality outcome and operational efficiency.

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Specific Protein Analyzer The i-Series has started with our initial model of Mispa i-the first of our offering for Specific protein analyzer. Mispa in Hebrew translates to new beginnings and we started to brand our instruments Mispa to highlight our constant search for innovation. This basic instrument provided for the requirement at hand, with 9 parameters helped us realize the requirement of the market and the flaws that needed to be rectified. To improve upon the Mispa i-, we started to develop the successor aiming to push this product with a very wide spectrum to analyze. As this thought grew and our aim clear, the development of the Mispa i2 progressed. A revolutionary equipment was thus conceptualized by our R&D. A semiautomatic Specific Protein Analyzer Mispa i2, launched in 2012 September, was a moment in time that created history. Patented for its dual channeling technology, this created ripples in the Indian IVD market as this new and innovative product broke all the constraints

AFFORDABLE ADVANCED BLOOD CELL COUNTERS, AN AGAPPE-LTTS INITIATIVE largely to the cost of the device. Sourcing ruby crystals from the Indian market helped the team meet the specifications with significantly reduced costs. Characterization of cell: This is the core task of the blood-testing device. The electronics challenge was to detect the microvolt d isturbance when a single cell passes the sensing zone. Achieving the signal conditioning of < 15 micro volts was a major challenge that was effectively solved by the LTTS team.

with 10 micro liters.

Due to the dilution factor it meant the amount of reagent used would be exponentially less. But handling the accuracy in dispensing the required volume change was a major challenge. Fluidic handling required consideration of blood viscosity and contamination risks as well.

Mission accomplished

The result of this partnership Advanced fluid ics: is developing an Achieving high perforadvanced yet afmance and efficiency in fordable blood fluidics was essential in cell counter that reducing cost per test, by bringing down the Thomas John (Managing Director) and Meena Thomas (COO & Director), has a wider reach AGAPPE with Shri A.M. Naik, Group Chairman, L&T and penetration amount of reagent used in developing per test. The team took markets. LTTS achieved significant reduction in capital costs on the challenge of reducing blood consumption and still meeting and in per-test costs, thereby making Hematological tests the needs. Most benchmark equipment performs blood tests conmore accessible and affordable. suming 15 to 18 micro liters. The LTTS team set out to achieve this of economical and space barriers that had been associated with Specific Protein Analyzer in the past. A 25 parameter Assay panel was carefully selected keeping in mind some of the most critical test that is needed in a lab for proper diagnosis. Each of these tests are given with an open vial stability of 45-75 days, so that even the smaller labs can make use with them. Mispa-i2 is a semiautomated specific protein analyzer that offers the benefits of high precision and quick turnaround results, for all protein assays. It also supports the clinical management of variety of disease, such as Diabetes, Cardiovascular risk, Inflammation and Kidney disease. A patented Dual Channel Shifting technology, that helps it to toggle between Nephelometer to Turbidimetry and vice versa as to provide you best sensitivity and linearity. A smart calibration card, that benefits hassle-free calibration at the lab site and helps to keep zero wastage in terms of reagents. Our minds did not stop at there, we were convinced that a better model would benefit the

masses. This led us to start our project for Mispa i3 which was launched in 2016, an automated Cartridge based specific protein analyzer that offers the benefits of fully Auto analyzer. With a cartridge-based system for the working, it offers a more precise and robust method to arrive at an error free result. Since the manual intervention is minimized, a more accurate result is obtained. The cartridge system also allows to keep a very minimal Reagent wastage. I believe these projects will make Agappe a formidable force in the IVD industry globally, caring for the unnoticed dimensions. Stepping into the path less travelled and creating a platform for others to follow. Sticking to this principle we can proudly say Agappe is moving ahead with the vision â&#x20AC;&#x153;To Establish Globally as a Premier In-Vitro Diagnostic Corporation and to be The Best Partner in the Diagnostic Field for the Welfare of Mankind.â&#x20AC;?

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Cover Story Infertility - An Overview

INFERTILITY NOT THE END OF THE ROAD Prof. Dr. D M Vasudevan, MBBS, MD (Biochem), FRCPath, Technical Director, AGAPPE

Not having a child after marriage is truamtic for many a couple. Infertility is quite common these days to a host of factors related to physical, mental and social issues. But the heartening thing is that infertility in men and women are now treatable thanks to the latest advances in medical science and technology. As such, infertility is not the end of the road today and there are bright tomorrows for disappointed couples

nfertility is defined as the inability to become pregnant after one year of marriage without resorting to contraception. A man is considered infertile if he has too few sperm or his sperm are too unhealthy to combine with a womanâ&#x20AC;&#x2122;s egg. Primary infertility is infertility in a couple who have never had a child. Secondary infertility is failure to conceive following a previous pregnancy. About 8-12 % of all couples have fertility

problems. Male infertility is responsible for 30% of infertility cases, another 30% are due to female infertility, and 30% are due to combined problems in both parts. In the rest 10% of the cases, no cause is found. Currently, female fertility normally peaks at the age of 24 and diminishes after 30 years of age, with pregnancy occurring rarely after age the age of 50 years. Male fertility peaks usually at the age of 25 and declines after 40 years of age.

Common causes in men and women The most common cause of female infertility is ovulatory problems. Male infertility is most commonly due to deficiencies in the semen quality. Low sperm count (Less than 15 million) is considered as suboptimal. Around one third of couples have difficulty conceiving due to a low sperm count. Other causes are low sperm mobility (motility) or abnormal shape of sperms. Other rare causes are testicular infection, undescended testicle (one or both of testicles remain in the abdomen, testicles are supposed to drop down from the abdomen into the scrotal sac at birth)., varicocele (varicose vein in the scrotum), block in ejaculatory ducts, testosterone deficiency,

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chromosomal abnormalities (Klinefelterâ&#x20AC;&#x2122;s syndrome), anemia, infections (especially sexually transmitted diseases), diabetes and thyroid disease. Exposure to pesticides, excess alcohol consumption, overweight or obesity and mental stress are other causative factors in males. In females, the ability to conceive starts to fall around the age of 32 years. A lack of folic acid, iron, zinc, and vitamin B12 can affect fertility. Sexually transmitted infections (Chlamydia, Gonorrhea, Mycoplasma) have a negative effect on fertility. Ovulation d isorders appear to be the most common cause of infertility in women. Ovulation disorders can be due to Polycystic ovary syndrome (PCOS) where the ovaries function abnormally and ovulation may not occur. If prolactin levels are high (hyperprolactinemia) may affect ovulation and fertility. An overactive or underactive thyroid gland can lead to a hormonal imbalance. Problems in the uterus or fallopian tubes can prevent the egg from traveling from the ovary to the uterus, or womb. This can occur after pelvic surgery and due to endometriosis. Some drugs such as non-steroid anti inflammatory drugs (aspirin), marijuana or cocaine may lead to fertility problems. Infertility may be caused by blockage of the Fallopian tube due to malformations, infections or scar tissue. Some women do not ovulate every month, which makes it harder to become pregnant. Early-onset menopause, which occurs before the age of 40. It may be due to an immune system disease, or a genetic syndrome. As a woman gets older, it becomes harder to get pregnant. Being overweight or underweight can affect fertility.

Obesity has a significant impact on male and female fertility. An increase in BMI is correlated with a decrease in sperm concentration, a decrease in motility and an increase DNA damage in sperm. Obese women have a higher rate of recurrent, early miscarriage compared to non-obese women.

Combined infertility In some cases, both the man and woman may be nfertile or sub-fertile, and the coupleâ&#x20AC;&#x2122;s infertility arises from the combination of these conditions. Factors that can cause male as well as female infertility are: DNA damage reduces fertility in female ovum, as caused by smoking, other xenobiotic DNA damaging agents (such as radiation or chemotherapy). DNA damage reduces fertility in male sperm, as caused by oxidative DNA damage, smoking, other xenobiotic DNA damaging agents (such as drugs or chemotherapy). Smoking, alcohol consumption, obesity and stress significantly increase the risk of infertility in both men and women. Diabetes mellitus, thyroid disorders, coeliac disease, adrenal disease, hypopituitarism are other general factors which affect both male and female reproduction. Antisperm antibod ies (ASA) have been considered as infertility cause in around 10â&#x20AC;&#x201C;30% of infertile couples. In both men and women, ASA production are directed against surface antigens on sperm, which can interfere with sperm motility and transport through the female reproductive tract. Obesity has a significant impact on male and female fertility. An increase in BMI is correlated with a decrease in sperm concentration, a decrease in motility and an increase DNA damage in sperm. Obese women have a higher rate of recurrent, early miscarriage compared to non-obese women.

Unexplained infertility About 10% of infertile couples have unexplained infertility. Possible problems could be that the egg may not enter the fallopian tube, transport of the zygote may be disturbed, or

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Cover Story Infertility - An Overview implantation fails. It is increasingly recognized that egg quality is of critical importance and women of advanced maternal age have eggs of reduced capacity for normal and successful fertilization.

Psychological and social effects The consequences of infertility are manifold and can include societal repercussions and personal suffering, which include distress, loss of control, and stigmatization, and a disruption in the developmental trajectory of adulthood. The further into treatment a patient goes, the more often they display symptoms of depression and anxiety. Patients with one treatment failure had significantly higher levels of anxiety, and patients with two failures experienced more depression when compared with those without a history of treatment. Marital discord often develops. In many cultures, inability to conceive bears a stigma. In closed social groups, a degree of rejection (or a sense of being rejected by the couple) may cause considerable anxiety and disappointment.

Developments in diagnosis of infertility

Blood tests will check hormone levels and genetics (for both men and women) and egg quality. Women may have additional tests. These could include: a) Transvaginal ultrasound, where the doctor can view images of the inside the uterus and fallopian tubes. b) An X-ray that involves injecting dye into uterus to look for blockages inside the fallopian tubes. C) A thin, flexible scope is inserted into the abdomen to give the doctor a better look at uterus and fallopian tubes, which could diagnose polyps, growths, and blockages. For men, the first test will be to collect a sample of semen to examine the sperm count, quality, and movement. Men may undergo further physical examination to rule out enlarged prostate, varicocele (enlarged veins inside the skin around testicles). A biopsy of the testicles may be necessary.

The latest treatment options Treatment will depend on many factors, including the age of the per-

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son, personal preferences, and general state of health. In the case of men, urgically removing a varicose vein in the scrotum may help. Blockage of the ejaculatory duct may be surgically corrected. Surgery is also useful for repairing the epididymal blockage, which is the structure that helps to transport sperm. In women, the teatment depends on the cause of infertility. The treatment for both men and women include lomiphene citrate, follicle stimulating hormone (FSH), human chorionic gonadotropin (hCG) and gonadotropin releasing hormone (GnRH). If the sperm are of good quality and the womanâ&#x20AC;&#x2122;s reproductive structures are good (patent fallopian tubes, no adhesions or scarring), a course of ovulation induction maybe used. Clomifene encourages ovulation in those who ovulate either irregularly or not at all, because of PCOS or other disorders. It makes the pituitary gland release more follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Metformin may help women with PCOS, especially when linked with insulin resistance. Follicle-stimulating hormone is produced by the pituitary gland that in turn controls estrogen production by the ovaries. It stimulates the ovaries to mature egg follicles. Human chorionic gonadotropin is used together with clomiphene, and FSH. The hCG can stimulate the follicle to ovulate. Gonadotropin-releasing hormone (Gn-RH) analogs can help women who ovulate too early, before the lead follicle is mature. It delivers a constant supply of GnRH to the pituitary gland, which alters the production of hormone, allowing the doctor to induce follicle growth with FSH. Bromocriptine inhibits prolactin production. Prolactin stimulates milk production during breastfeeding. Women with high levels of prolactin may have irregular ovulation cycles and fertility problems. Injectable fertility drugs can sometimes result in multiple births, for example, twins or triplets. The chance of a multiple birth is lower with an oral fertility drug. Careful monitoring during treatment and pregnancy can help reduce the risk of complications. The more fetuses there are, the higher the risk of premature labor.

Fer tilization takes place outside the body, and the fertilized egg is reinserted into the womanâ&#x20AC;&#x2122;s reproductive tract, in a procedure called embryo transfer. IVF is useful in overcoming blocked or damaged tubes, endometriosis, poor ovarian reserve, or poor sperm count. Surgical options for infertile women

If the fallopian tubes are blocked or scarred, surgical repair may make it easier for eggs to pass through. Endometriosis may be treated through laparoscopic surgery. The surgeon can remove implants and scar tissue, and this may reduce pain and aid fertility. Intrauterine insemination (IUI) The doctor introduces sperm into the uterus during ovulation, via a catheter. At the time of ovulation, a fine catheter is inserted through the cervix into the uterus to place a sperm sample directly into the uterus. In these methods, fertilization occurs inside the body. IUI is more commonly done when the man has a low sperm count, decreased sperm motility, or when infertility does not have an identifiable cause. Assisted reproductive technology (ART)

If the above said treatments fail, the patient undergo in vitro fertilization (IVF). The IVF and related techniques (ICSI, ZIFT, GIFT) are called assisted reproductive technology. ART techniques generally start with stimulating the ovaries to increase egg production.

Gonadotropin-releasing hormone (Gn-RH) analogs can help women who ovulate too early, before the lead follicle is mature. It delivers a constant supply of Gn-RH to the pituitary gland, which alters the production of hormone, allowing the doctor to induce follicle growth with FSH.

In vitro fertilization (IVF). This requires stimulating the ovaries with hormones and removing eggs from the woman. The eggs are fertilized with sperm in a laboratory. Once an embryo develops, it is placed into the womanâ&#x20AC;&#x2122;s uterus. While they can be successful, there is no guarantee that IUI or IVF will result in a pregnancy. Sometimes the embryo is frozen for future use. Fertilization takes place outside the body, and the fertilized egg is reinserted into the womanâ&#x20AC;&#x2122;s reproductive tract, in a procedure called embryo transfer. IVF is useful in overcoming blocked or damaged tubes, endometriosis, poor ovarian reserve, or poor sperm count. Intracytoplasmic sperm injection (ICSI) This technique is used in case of poor semen quality. Here one single healthy sperm is directly injected into mature egg. The likelihood of fertilization improves significantly for men with low sperm concentrations. The fertilized embryo is then transferred to womb. This may be used if IVF has not been effective, if there has been poor embryo growth rate, and if the woman is older. In 1978, the first baby was born as a result of IVF. By 2014, over 5 million people had been born after being conceived through IVF. Third party assisted ART This is when another person helps a couple to get pregnant. The third person can help by donating sperm, donating eggs, or donating embryos. ART procedures sometimes use donor eggs, donor sperm, or previously frozen embryos. It may also involve a surrogate or gestational carrier. A surrogate is a woman who becomes pregnant with sperm from the male partner of the couple. A gestational carrier becomes pregnant with an egg from the female partner and the sperm from the male partner.

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Life Story Kanupriya Agarwal

AMAZING STORY OF INDIA’S

FIRST TEST TUBE BABY India’s first test tube baby, Kanupriya Agarwal (now Kanupriya Didwania) and world’s second test tube baby was born on October 3, 1978 at Kolkata, just 67 days after the world’s first test tube baby was born. Dr. Subhas Mukhopadhyay was the mastermind behind that. Dr. Mukhopadhyay and British scientists, Robert G Edwards and Patrick Steptoe - creators of the world’s first testtube baby - started work almost at the same time.

It was on July 25, 1978, the world’s first test tube baby was

born. Louise Joy Brown was born at Oldham and District General Hospital in Manchester, England to parents Lesley and Peter Brown. Louise’s mother Lesley Brown had suffered years of infertility due to blocked fallopian tubes. In November 1977, she underwent the then-experimental in vitro fertilisation (IVF) procedure. A mature egg was removed from one of her ovaries and combined in a laboratory dish with her husband’s sperm to form an embryo. The embryo then was implanted into her uterus a few days later.

British gynaecologist Patrick Steptoe and scientist Robert Edwards were the masterminds behind this technique. The parents faced intense public scrutiny after the news came out through newspapers. It also made headlines around the world and raised various legal and ethical questions.

The story of Kanupriya Agarwal Kanupriya Agarwal, now known as Kanupriya Didwania is India’s first test tube baby born in Kolkata, just 67 days after the world’s first test tube baby was born under the able hands and mind Dr Subhas Mukhopadhyay. Incidentally, it may be recalled that Dr Mukhopadhyay and British scientists Robert G Edwards and Patrick Steptoe—creators of the world’s first test-tube baby—started work almost at the same time. Dr Mukhopadhyay teamed up with Sunit Mukherji, a cryobiologist, and Saroj Kanti Bhattacharya, a gynaecologist at Kolkata. Not only had their attempt at in-vitro fertilisation succeeded, they had also successfully achieved the cryopreservation of an eight-cell embryo — storing it for 53 days, thawing in DMSO reagent and replacing it into the mother’s womb — a full five years before anyone else would do so. He was also the first to use human menopausal gonadotropins (hMG) to stimulate ovaries to produce extra eggs. He was far ahead of his time in successfully using an ovarian stimulation protocol before anyone else in the world had thought of doing so.

Kanupriya Agarwal

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A few experts were of the view that Dr Mukhopadhyay’s method was even superior to the one used by the English scientists, Robert G Edwards and Patrick Steptoe for the birth of the

world’s first test-tube baby (they did not freeze the embryo and their laparoscope technique of extracting eggs from ovaries was more difficult). Dr Mukhopadhyay’s method called cryopreservation (to preserve the human embryo) is currently the preferred technique of medically assisted reproduction worldwide.

Kanupriya’s Challenges Meanwhile Kanupriya’s parents were bombarded with questions by the media including intrusive questions about their sex life. For them, it was a shock. A conservative Marwari family in Kolkata, they had been facing social ostracisation for being childless for 13 years.

Kanupriya Agarwal celebrating her 40th birthday Pune with Professor Sunit Kumar Mukharjee, an Embryologist who had worked with Dr Subhash Mukharjee in creating Durga.

It was through common friends they got introduced to Dr Mukhopadhyay. Much like the public scrutiny in England, the case wasn’t d ifferent with the parents of Kanupriya and Dr Mukhopadhyay. The doctor was prevented from carrying out further work on IVF and transferred away from Kolkata. He was also prevented from going to Tokyo to present a paper. “Imagine the degree of stigma associated with being childless in 1970s India that prompted even my otherwise conventional parents to undergo what was at that time a high-risk experiment,” says Kanupriya Didwania, who is now a mother to seven year old daughter. To avoid media attention, Kanupriya was sent to her grandmother’s place soon after her birth. To maintain her privacy, her grandfather even rustled up a name- ‘Durga’, since she was born on the first day of Durga Puja.

Eye-opening Flashback Kanupriya had a normal life at first even though being the first test-tube baby was incidental. (Dr. Mukhopadhyay committed suicide while she was three years old) Her grandparents were extremely progressive and they accepted her. “Since my grandparents accepted me, everybody had to. People had varied perspective about me, but when they saw me growing normally everything fell in place,” adds her. She grew up in a jovial Marwari neighbourhood in Kolkata and went to La Martiniere’s School. Her parents did a wonderful job of keeping all the pressure away and

helping her grow as a mature, reasonable individual. “It was not easy for them. They were made to feel like accomplices of Dr Mukhopadhyay in his misdeed. There were insinuations of the worst kind. However my parents have always been truthful to me and never glossed over the details of my birth. I was about seven years old when my father first told me that Ma had difficulty in conceiving as we had to take some help from Dr Mukhopadhyay,” recalls she. She vaguely remembers taken on a tour to Dr Sunit

“Imagine the degree of stigma associated with being childless in 1970s India that prompted even my otherwise conventional parents to undergo what was at that time a high-risk experiment,” says Kanupriya Didwania, who is now a mother to seven year old daughter.

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Life Story Kanupriya Agarwal

DR. SUBHASH MUKHOPADHYAY THE FORGOTTEN HERO OF IVF D r. Subhas Mukhopadhyay had achieved an incredible feat way back in 1978 and yet received almost no acknowledgement from India’s scientific and medical community. Born on January 16, 1931, in Hazaribagh district of present-day Jharkhand, Dr Mukhopadhyay was the son of a doctor and studied at the National Medical College in Kolkata after completing his schooling. Fascinated by innovations in gynaecological surgery from his early days as a medical student, he completed his PhD in reproductive physiology from the University of Calcutta before going to Edinburgh University in the UK for a PhD in reproductive endocrinology. On his return to India in 1967, the dedicated doctor started researching ovulation and spermatogenesis. Soon after, he teamed up with Sunit Mukherji and Saroj Kanti Bhattacharya to work on a method of in-vitro fertilisation (IVF) for a patient which resulted in the birth of India’s first test tube baby with only some general apparatus and a refrigerator. Mukherji’s lab, the cryobiologist in the team which he had set up in Dr. Mukhopadhyay’s honour and the watching the instruments used there when she was ten years old. Kanupriya was about 13 years old when journalists started coming to her house. By then the controversy surrounding Dr Mukhopadhyay was well-known. Her father hated the idea of people photographing her. They arranged her friends to ‘protect’ her from the glare of reporters and photographers. She used to discuss the technology behind her birth with her friends back then. “We were kids; we did not really understand the trauma behind it. I am told I always wanted to be a doctor when I was young, and then a psychologist,” says Kanupriya “Everyone forgot in a couple of months. I didn’t grow up with people recognising me or my name. And I didn’t speak

“Everyone forgot in a couple of months. I didn’t grow up with people recognising me or my name. And I didn’t speak out. It’s not like science is accorded that sort of importance in our country,” says Kanupriya.

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out. It’s not like science is accorded that sort of importance in our country,” says Kanupriya. But when she turned 22, Dr T C Anand Kumar came in search of her. Dr. Anand Kumar was officially credited as the first to deliver the first test tube baby in India, eight years after the birth of Kanupriya. Dr Sunit Mukherji had passed Dr. Mukhopadhyay’s notes to him. “Dr. Kumar was one of the bravest people I know. He opposed Dr Mukhopadhyay vehemently, yet he was the one who painstakingly went through those notes, and accepted that he had been wrong. He convinced the Indian Council of Medical Research, and commemorated Dr Mukhopadhyay on my 25th birthday,” she remembers. Kanupriya did her MBA from Symbiosis University, Puna and got a job with Perfetti Van Melle as a marketing personnel and later become a brand manager splitting her time between Mumbai and Delhi. Around then, Dr Mukhopadhyay was given the recognition he deserved years before. “My colleagues bombarded me with questions, about why I had concealed my identity. I always tell people, that I don’t walk up to you and tell you my favourite colour because it won’t make a difference to your life. The story of my birth is something like that,” says her. She got married in 2006 and conceived naturally. She says she will tell her story to her child in the future. Talking about her kid’s childhood Kanupriya said that nothing is different in her daughter’s childhood than hers.

Testimonials On October 3, 1978, Dr. Mukhopadhyay and his team announced the birth of the world’s second test tube baby and India’s first in Kolkata. However Dr. Mukhopadhyay was greeted with disbelief and disdain from the Indian scientific and medical establishment. Although an official scientific committee was formed to investigate and evaluate his claim, there weren’t any qualified personnel to do so in the committee. Moreover, the absence of Durga and her parents also added to it. Durga’s parents weren’t interested in publicising their or their daughter’s birth. The committee concluded his claims were bogus. Even the government was against Dr. Mukhopadhyay, denying him permission to go abroad to present a paper. To discontinue his work in IVF, they even transferred him to Kolkata’s Regional Institute of Ophthalmology in June 1981. Frustrated and humiliated, he hanged himself to death on June 19, 1981. His wife Namita found his body along with a suicide note which read: “I can’t wait everyday for a heart attack to kill me.” Recognition to Dr. Mukhopadhyay came later through the efforts of Dr. T C Anand Kumar who was officially named as the first creator of the test tube baby in India. Little did he know that Dr. Mukhopadhyay had succeeded in it eight years before that. Dr. Kumar made genuine efforts in reversing the wrong meted to Dr Mukhopadhyay by the earlier government departments. It’s worth noting that Dr. Mukhopadhyay’s life and death inspired Ramapada Chowdhury’s novel Abhimanyu and Tapan Sinha’s national award winning movie Ek Doctor Ki Maut.

A Few Self-reflections Sometimes, Kanupriya wonders how different things would have been for Dr. Mukhopadhyay if her parents had been more forthcoming. Yet neither Dr Mukhopadhyay nor his wife Namita had any grudge against the Agarwals for not having spoken out. Kanupriya speaks fondly of the two of them as family friends and often credits him as her scientific dad. Even after Dr Mukhopadhyay died, Namita would drop by often to meet ‘Durga.’ Namita often addressed Durga as her husband’s only child. “I feel doctors really researched their way and helped my parents who really wanted a child then. It was an era in which Dr Mukhopadhyay, who became the first physician to help my parents with me, never recognised truly for his efforts. Recognition came late, but it did. However, my mother could never conceive again because her fallopian tubes were blocked. I am their only child and I am honoured that the doctors did their best to help them have me.” She added that her parents faced a lot of brunt because of her ‘status’ then and faced many questions, but now everything has become easier. I am showered with a lot of love and respect,” she said. I’m proud to be living proof of one of the greatest medical achievements in the world. But I don’t want to be treated like a trophy and certainly won’t be the poster girl of the Indian IVF industry. I am neither a doctor, nor a psychologist, but I believe that I need to speak up for it, if only to clear a good man’s name, she says while signing off.

Business Partner

WE ARE IMPRESSED WITH THE ENTHUSIASM OF AGAPPE O

Mr. K T Purushothaman, Managing Director, Glastronix LLP, Bangalore.

ur initial interaction with M/s Agappe started about 3 years ago. Since then the interaction has grown significantly to meet their product development requirements. We have been very satisfied with the team from Agappe including officers from different departs like design, supplier development, purchase and senior managers. I would like to point out the humble and professional nature of dealing with us which is common across alll the team members and we feel that we are part of same family, even though we have not met earlier. We were also very impressed with the clarity and enthusiasm of the Agappe team working in a high technology environment creating products in India for customers world-wide! The openness during discussions and ability to work seamlessly with our team and implement changes, all of which was done keeping in the mind to ensure that the best inputs go into the products to meet the time to market requirements as well as getting it done right. Glastronix is privileged to provide its services in the areas of sheet metal parts development, machining, electrical and electronics areas that we are familiar with and extend the optimised solutions appropriate to the products and applications. Our long experience in varied segments including our knowledge of machining, electrical products and electronics helps us understand customer applications. With key capabilities established inhouse the ability to try new concepts and cost effective solutions allows us to respongd to customer challenges. We look forward to a strengthening our relationship with M/s Agappe and wish them success in all their endeavours.

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Interview

Dr. Kamini A. Rao

ADDRESSING INFERTILITY WITH

A HUMANE PASSION E

Padmashri Dr. Kamini A Rao, M.B.B.S., M.D., Founder & Medical Director, Milann Infertility Clinic, Bangalore.

Infertility is a medico social issue and it needs to be addressed with a humane passion says Padma Shri Dr. Kamaini A Rao, renowned expert in the field of reproductive medicine and assisted reproduction. In an exclusive interview to Techagappe, she says that the social environment of the patients must be taken care of with top priority in treating the infertile community. In an exclusive interview to Techagappe, she shares her knowledge and views relating to reporductive technology. Excerpts...

Padma Shri Dr. Kamini A Rao is one of the pioneers in the field of

assisted reproduction in India with a distinguished clinical and research career in reproductive medicine, specialising in reproductive endocrinology, ovarian physiology and assisted reproductive technology. She is also the Medical Director of Milann, Bengaluru specialising in reproductive medicine and is also the Chairperson of the International Institute for Training and Research in Reproductive Health. Besides authoring and publishing more than 40 medical books, she is also a recipient of a host of awards including the Karnataka State Rajyotsava Award and the Outstanding Woman Obstetrician & Gynaecologist Award amongst others. Techagappe : What instilled the desire for you to turn into medical studies and later specialise in reproductive endocrinology? Dr. Kamini A Rao: When I was young, I never thought to become a reproductive endocrinologist. I wanted to become a Professor in Chemistry. Organic chemistry was something which always fascinated me with its ‘chains’ and ‘structures’ and so. I wanted to publish some research papers also in it. However my father wanted me to become a doctor and he told me I can still teach students even after pursuing MBBS in the medical colleges. Thus I was redirected to medical studies and I secured a seat in St John’s Medical College, Bengaluru and later did Obstetrics and Gynaecology from Vanivilas Hospital Bengaluru. I couldn’t practice here as I had to move to UK as soon as I finished my course. There I was exposed to foetal medicine. It was a time when they started looking at pregnant woman as two persons rather than one person. I did MCH in Foetal- Maternal Medicine. Again, my parents were not in favour of Foetal Medicine and I had to turn to my minor subject- infertility and gynaecology ultrasound when I returned to India. Our course had one major subject and two minor subjects.

Dr. Kamini Rao

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Obviously there was nothing like reproductive endocrinology when I was born. That came over years. Basically it was RMP, LMP (Li-

Dr. Kamini A. Rao sharing her experiences with Gowri Sankar, Asst. General Manager, AGAPPE censed Medical Practitioner). The MBBS itself was the ultimate during that time. The number of people who did MD was much less. In the last two or three decades, you have seen a lot of sub specialities arising only because of the so much of knowledge that has accumulated in the field of medical science. Patients also want to go to those doctors so that they have an experienced doctor who knows everything about it. Earlier the general surgeon will do the cancer surgery but today the situation has changed. People are now looking at sub specialities and sub-sub-specialities. Today a student who passes out MBBS has so many opportunities

"Now it’s almost 30 years into practice and I find that a lot of people recognise my work. In spite of so many clinics mushrooming up in several parts of the city, we still don’t need advertising. Excel is not something you advertise but something you practice. And when you practice it, you don’t need advertisement".

so that they don’t have to go through the routine run of the mill things like you must do MD and so. Techagappe : How is treating infertility is different from treating other diseases? Dr. Kamini: Infertility is a medico-social condition. I wanted to make something that could make a difference to the public. The emotions of a lady who had conceived third time and a lady who has never had a baby even after 10 years of their marriage are different. In the case of latter, the value she will place on the child and the value the public will place on the child are much different. Instead of doing ‘mass’ work, I thought of doing ‘fine’ work and will see where I can make a difference. Now it’s almost 30 years into practice and I find that a lot of people recognise my work. In spite of so many clinics mushrooming up in several parts of the city, we still don’t need advertising. Excel is not something you advertise but something you practice. And when you practice it, you don’t need advertisement. It requires a lot of listening and counselling. There is so much of psychological trauma associated with infertility and sometimes people forget it and look at that person as a uterus or ovary or a tube. When you become organ centric, you can’t practice infertility. You have to be a person centric- mind and

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Interview

Dr. Kamini A. Rao

body. That is where I find myself different. You have to treat the mind first, understand what the patient is not telling you. What they hide will not come in the first visit and what they tell you first is indeed to ‘test’ the doctor. Many times, we don’t even need technological intervention. We just need to hear them out. They could be psychological stress which might be acting as a roadblock and we can easily rectify it. Some patients will ask questions to us with the acquired knowledge over the internet. My advice is that doctors must not get irritated to it and handle it softly. Treating infertility is not like treating sick people in the general hospital. They are well and have no problem except they can’t reproduce or they don’t have the right advice to do so. I would say such doctors must be empathetic. The social environment of the patients must be also something to be taken care of. You should be careful not to put down either the husband or wife although in most cases the latter suffer more. You should be very sensitive to the home surroundings. That sensitivity is to be inculcated to the present doctors as there are no textbooks which provide such information. The importance of mind over matter is what I feel is important. (Blurb) A patient-doctor trust is to be made which takes time. I believe

"A patient-doctor trust is to be made which takes time. I believe it’s a two way track. Medicine is not static. Just because you did MD doesn’t mean the end of the story. You have to redefine it. If you don’t do it today, you are illiterate tomorrow. You have to keep pace with it". it’s a two way track. Medicine is not static. Just because you did MD doesn’t mean the end of the story. You have to redefine it. If you don’t do it today, you are illiterate tomorrow. You have to keep pace with it. Techagappe : What is the status of foetus medicine in India now? Dr. Kamini: Very good. In fact, that is now very much acknowledged. When I came back in 1989 from the UK, people thought I was mad considering the choice I made in my studies. But when I published my first book ‘A Handbook of Prenatal Diagnosis Reproductive Genetics’, people become curious and wanted to know more about it. I always believed that books could be a powerful tool to change people. Techagappe : Milann has so many credits to its list like India’s first SIFT baby and GIFT baby to have conceived here. Tell us more about it. Dr. Kamini: Milann Pioneered the SIFT (Semen Intra Fallopian Transfer) technique in assisted reproduction in the year 1991. Milann was the first fertility center in India to have a SIFT baby. Prior to it we helped conceive baby through Gamete Intra Fallopian Transfer (GIFT) technique at Milann. South India’s first ICSI (Intra Cytoplasmic Sperm Injection) baby in 1997 through Micromanipulation Technique was also done in Milann. We also became the first fertility clinic in South India to deliver a baby by Laser Assisted Hatching. Techagappe : You are credited for establishing the first semen bank in South India. What were the challenges you faced?

Dr. Kamini Rao receiving Padmashree Award from former President of India, Shri. Pranab Mukherjee

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Dr. Kamini: Many times we found out that in the insemination process, the sample quality was very poor. In more than three circumstances, I found that collecting and storing semen was helpful. First, I needed two or three samples so that I can concentrate on the samples and get at least one good sample. The second thing was the people who had abnormal opening of the urethra- instead of having the opening in the centre if the opening is in the bottom, such people might not be able to have sex. In such cases, the best thing to be done is to take the sample and to freeze it and use it when ovulation happens. Then we can inseminate it. The third set was group of people who always travelled like travelling sales men, medical representatives and so.

ASSISTED REPRODUCTIVE TECHNOLOGY

Assisted reproductive technology (ART) includes medical procedures used primarily to address infertility. This subject involves procedures such as in vitro fertilization, intracytoplasmic sperm injection (ICSI), cryopreservation of gametes or embryos, and/or the use of fertility medication. When used to address infertility, ART may also be referred to as fertility treatment. ART mainly belongs to the field of reproductive endocrinology and infertility. Some forms of ART may be used with regard to fertile couples for genetic purpose. ART may also be used in surrogacy arrangements, although not all surrogacy arrangements involve ART. I urged them to keep their samples so that we can work on them even if they are away. The collected samples were put barcode and kept. We also thought of collecting samples from the donors too. The samples also underwent tests for diseases and were released only after six months after they turned negative in tests. At first, we didn’t charge anyone for it. But later more and more people came forward to keep their samples frozen with a fee. Techagappe : What is the social attitude towards male and female infertility? Dr. Kamini: If you compare it with the 90’s, it has changed a lot. Back then people were scared to address this issue. Even the doctors were scared to address the issue. It was used to put under the ‘carpet’. They felt that whatever you talk about male infertility is a bedroom scene rather than a boardroom. I insist that husbands should be accompanying their wives for IVF treatment so that I can see their attitude. The art of counselling helps to take care of the ego there. Techagappe : According to you, what is the ideal time when a couple must think of IVF treatment? Dr. Kamini: I think when the couple want a baby, they should try. After one year, if there are no results despite regular periods, sperm counts being fine and tubes are being open, then, I think they

should seek help. Based on the findings of the doctor, you can go ahead and try. It depends upon the age, the number of years infertile, the semen parameters, the tube status, menstrual status, the hormone profile etc. To be or not be a mother is a woman’s decision. Our job is to only advice around that problem. The final decision will be of the mother. Techagappe : Your association with professional organisations? Dr. Kamini: I’m always an association person. I’m the youngest FOGSI (Federation of Obstetric & Gynaecological Societies of India) President till date. I was also invited and made the President of Indian Society for Assisted Reproduction (ISAR) during 2006-2008. I never underwent elections for that post. Techagappe : About Milaan and future plans Dr. Kamini: The hospital has now 8 centres. We do roughly around 2000 cycles per year. I want this to be an organisation that looks at 3600. One there should be a social commitment. There should be an educational component, research component and a service delivery component. When you have all these put together then there will be a healthy turnout of good professionals, ethical practices, research to get new modalities and to spread this knowledge around the villages.

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Promotion AGAPPE’s Ferritin

FERRITIN: THE MOST SENSITIVE AND SPECIFIC

MARKER OF IRON DEFICIENCY Bintu Lijo, Manager - Customer Technical Support, AGAPPE. Serum ferritin is widely used for diagnosis and monitoring many diseases associated with iron overload and iron deficiency. Iron deficiency is the most common nutritional deficiency and the leading cause of anaemia in the world. The tests used most often to detect iron deficiency include haemoglobin, haematocrit, serum ferritin, serum iron and iron-binding capacity (IBC, UIBC or TIBC), Transferrin etc. Among these tests, Serum ferritin is the most important test and it is a valuable clinical tool for both the evaluation of common iron deficiency diseases and for evaluation of hereditary and acquired iron-overload conditions. What is Ferritin?

Serum ferritin was discovered in the 1930’s. Serum ferritin is often referred to as the body’s storage form of iron. The amount of ferritin which is found in the blood reflects the amount of total iron available to our body. The body will signal the cells to release ferritin when it is required to make more red blood cells. The ferritin then binds to transferrin to transport it to where new red blood cells are made. Serum ferritin is elevated in conditions of iron overload, liver disease, alcohol abuse, nicotine product abuse (used to stop smoking) and in inflammation. Serum ferritin is low in people who are iron deficient.

Why Ferritin test is important? Ferritin was developed as a clinical test in the 1970’s. Ferritin is a blood protein that contains iron. A ferritin test helps to understand how much iron our body stores. If a ferritin test reveals that your blood ferritin level is lower than normal, it indicates your body’s iron stores are low and you have iron deficiency anemia. If the ferritin test shows higher than normal levels, it could indicate that you have too much iron in store. It could also indicate liver disease, rheu-

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matoid arthritis, other inflammatory conditions or hyperthyroidism. Serum ferritin is the most important test because it helps to distinguish between iron deficiency anaemia and anaemia of inflammatory response. Also, when compared with other iron status parameters, the biological variation is less for Ferritin thus making it one of the most useful parameters. So, this test is used globally to monitor low and high levels of iron. Both high and low iron/ferritin levels may indicate a serious underlying problem. If left unchecked, both low and high levels of iron may lead to many other serious health problems including heart failure. Detection of ferritin values above 3000 ng/mL should lead to the consideration of Still’s disease when there is an acute febrile illness without evidence for bacterial or viral infections, serum ferritin being suitable for monitoring treatment. Adult -Onset Still’s disease (AOSD) is a rare type of inflammatory arthritis that features fevers, rash and joint pain. But, in patients with chronic kidney disease, serum ferritin is a less robust marker of bioavailable iron.

What does the test result mean? Ferritin levels are often evaluated in conjunction with other iron tests.

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Cover Story IVF in developing countries

IN VITRO FERTILIZATION IN DEVELOPING & LOW RESOURCE COUNTRIES

Despite a record of 5 million IVF babies born in the world, the treatment of infertility by effective methods remains largely the preserve of developed countries. Most infections causing tubal damage are preventable, and assisted conception can treat the infertility. However, assisted conception, despite being available for nearly three decades, is either unavailable or inaccessible to most residents of resource-poor countries. Dr. Gautam Allahbadia MD, DNB, FNAMS, FCPS, DGO, DFP, FICMU, FICOG

Founder and Medical director, Rotunda - The Centre For Human Reproduction, Bandra, Mumbai, India

Despite a record of 5 million IVF babies born in the world, the treatment of infertility by effective methods remains largely the preserve of developed countries. Most infections causing tubal damage are preventable, and assisted conception can treat the infertility. However, assisted conception, despite being available for nearly three decades, is either unavailable or inaccessible to most residents of resource-poor countries. Provision of assisted reproductive technology (ART) to overcome both female and male infertility is in line with the reproductive

rights agenda developed at the International Conference on Population and Development (ICPD) at Cairo 15 years ago. In addition to the right to control fertility, reproductive rights must encompass the right to facilitate fertility when fertility is threatened. Facilitation of fertility may require resort to ART among both men and women. There is an increased need for low-cost procedures in treating infertility particularly in developing countries. One of the United Nationâ&#x20AC;&#x2122;s Millennium Development Goals was for universal access to reproductive health care by 2015, and WHO has recommended that infertility be considered a global health problem and stated the need for adaptation of ART in low-resource countries. Murage et al, a renowned medial professional conducted a survey in a developing country (Kenya) to gage the extent of subfertility and the current state of ART service provision and explore factors limiting access to ART services. A total of 47 responses (25 %) were received after completion of the survey. The overall rate of sub-fertility was 26.1 % among the gynaecology consultations, with 50 % being attributed to tubal factors and 15 % to male factors. Assisted reproductive service provision (IVF/intracytoplasmic sperm injection) was severely limited to only three units, despite the reported high rate of tubal disease.

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The high cost of treatment, patients’ limited finances, and limited local services were almost universally cited as the main barriers to ART services in Kenya. The authors summarized that the demand for ART in developing countries is never in doubt. Simplified, less costly, and more accessible ART approaches need to be considered in developing countries, even though the benefits and outcomes of such approaches may not be apparent immediately.

Discussion Three ethical concerns are often mentioned specifically with regard to developing countries: (a) the “overpopulation argument”; (b) the limited resources argument; and (c) the ethical problem of poorly trained practitioners offering their services to unsuspecting and uninformed infertile individuals or couples. Each argument was explored in some detail in a landmark published study, with the conclusion that ethical problems do, in fact, exist but are not unique to developing countries alone. Nevertheless, the difficulties relating to reproductive technologies are likely to be greater in the developing countries than in developed ones because of limited resources and a larger number of poor people residing in the former.

Intrauterine insemination Intrauterine insemination was used long before the advent of in vitro fertilization. During the last 30 years, however, intrauterine insemination has evolved with the introduction of ovulation-stimulating protocols and sperm preparation methods taken from assisted reproduction techniques. Costs have risen, but the success rate has not risen to the same extent. An African study group has developed a simple intrauterine insemination technique, which may be performed in developing countries, without the need of sophisticated equipment, costly materials, media, or disposable insemination catheters; it is quite inexpensive and may be performed by trained staff, such as nurses or midwives. In this study, 20–27 % of the couples remained clinically pregnant after an aver-

IVF is the definitive line of treatment for many couples. Stimulation cycles are associated with risks of ovarian hyperstimulation syndrome and multiple pregnancy.

age of 3.5–3.8 intrauterine inseminations procedures.

Invitro Fertilization IVF is the definitive line of treatment for many couples. Stimulation cycles are associated with risks of ovarian hyperstimulation syndrome and multiple pregnancy. This study from Egypt evaluates the client acceptability of stimulated versus natural cycle IVF among couples attending one infertility clinic, with respect to cost and pregnancy outcome. Of the patients who were indicated for IVF, 15 % (16/107) cancelled, due mostly (12/16, 75 %) to financial reasons. The majority of patients who completed their IVF treatment (82/91, 90.1 %) felt that the price of the medical service offered was high, and 68.1 % (62/91) accepted the idea of having cheaper drugs with fewer side effects, but with possibly lower chances of pregnancy. Natural cycle IVF has emerged as a potential alternative option that might be suitable for patients worldwide, especially in developing countries. A Thai group presented their “Simplified IVF” program at Ramathibodi Hospital. Some steps of the conventional IVF procedures have been modified because of the limitation of resources. Simplification of procedures enabled the IVF service to be available in a centre with limited resources without compromising the results. Other advantages as outlined by the authors are improvement of the patient’s convenience, cost savings, and less time consumed as well as being less stressful. In India, we have been trying to make IVF more affordable to ensure a wider reach across the socio-economic strata with introduction of cheaper and more patient-friendly Assisted Conception procedures without compromising on results. Routine IVF (IVF), is slowly being challenged by simpler and more

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Cover Story IVF in developing countries cost-effective methodologies. These include z Natural cycle IVF (nIVF). z Minimal stimulation IVF (msIVF). z IVF Lite (minimal stimulation IVF + vitrification + accumulation of embryos + remote embryo transfer) (msIVF + ACCUVIT + rET). A minimal stimulation IVF cycle is defined either as (a) a stimulation regimen in which gonadotropins are administered at a lower-than-usual dose and/or for a shorter duration throughout a cycle in which GnRH antagonist is given as cotreatment; or (b) a stimulation in which oral compounds (e.g., antiestrogens) are used either alone or in combination with gonadotropins and GnRH-antagonists. Mild stimulation protocols reduce the mean number of days of stimulation, the total amount of gonadotropins used, and the mean number of oocytes retrieved. The proportion of high-quality and euploid embryos seems to be higher compared with conventional stimulation protocols, and the pregnancy rate per embryo transfer is comparable. With the reduced costs, the better tolerability for patients, and the less time needed to complete an IVF cycle, these mild approaches are gaining a permanent foot-hold in cost-sensitive economies. Intravaginal culture (IVC), also called INVO (intravaginal culture of oocytes), is an assisted reproduction procedure where oocyte fertilization and early embryo development are carried out within a gas permeable air-free plastic device, placed into the maternal vaginal cavity for incubation. INVO can be

Intravaginal culture (IVC), also called INVO (intravaginal culture of oocytes), is an assisted reproduction procedure where oocyte fer tilization and early embryo development are carried out within a gas permeable air-free plastic device, placed into the maternal vaginal cavity for incubation.

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performed in a physicianâ&#x20AC;&#x2122;s office or in a satellite facility of an IVF center. The INVO procedure consists of fertilization of oocyte(s) and early embryo development in the INVO cell device placed into the maternal vaginal cavity for incubation. The vaginal cavity replaces the complex in vitro fertilization (IVF) laboratory. Over 800 cycles have been published worldwide which showed a clinical pregnancy rate of 19.6 %. The participation of the patient in the process of fertilization and early embryo development is a psychological benefit that creates a high level of acceptance of INVO. In a recent study the authors assessed the outcome of the INVO procedure, using the recently upgraded INVO cell device, in combination with a mild ovarian stimulation protocol. A total of 125 cycles were performed. On average, 6.5 oocytes per cycle were retrieved, and a mean of 4.2 were placed per INVO cell device. The cleavage rate obtained after the INVO culture was 63 %. The procedure yielded 40, 31.2, and 24 % of clinical pregnancy, live birth, and single live birth rates per cycle, respectively. These published results hold promise that the INVO procedure is an effective alternative treatment option in assisted reproduction that shows comparable results to those reported for existing IVF techniques. A study performed last year in Belgium with another in vitro cheap culture device has shown that low-cost IVF for the developing and poor-resource countries is feasible and effective, with delivery rates not much different from those achieved in conventional IVF programs. Klerkx et al. led a 11-month prospective study at Genk in which oocytes were cultured according to (a) regular IVF culturing, or (b) the tWE lab IVF culture system (50/50 %). The primary outcome parameter was embryo quality at day 3; secondary outcome parameters were embryo implantation rate and ongoing pregnancy rate. Only first IVF attempts in women

<36 years with e”8 oocytes were included. Severe male factor infertility cases were excluded. They always performed single embryo transfer (SET). In their system, an optimal culture environment was reproducibly obtained without the need for medical gases, complex incubation equipment, and expensive infrastructure. Similar rates of fertilization and cleavage were observed in both groups. In two cases, no fertilization occurred, all embryos were cryopreserved in 3 cycles because of an increased risk of ovarian hyperstimulation. SET was performed in the remaining 35 IVF cycles. In 23 out of 35 cycles (65.7 %), the top-quality embryo selected by an independent embryologist originated from the tWE lab system. In this group, the implantation rate was 34.8 % (8/23) with an ongoing pregnancy rate of 30.4 % (7/23), and one miscarriage at 8 weeks gestation. Up to December 31, 2012, three healthy tWE lab babies have been born vaginally. This proof-of-principle study, as called by the investigators, suggests that infertility care may now be “universally accessible.” The authors showed that the IVF methodology can be significantly simplified and can result in successful outcomes at levels that compare favourably to those obtained in high-resource programs. They concluded that the cost of their simplified culture system is between 10 and 15 % of the current costs in Western-style IVF programs and computed that a cycle of IVF with the simplified procedure can be performed for around Rs 16,000 (Euros 200). The low-cost culture system developed by this US–Belgian team of researchers, which can fit into a shirt pocket, is designed

BRAND REACH Great products and after-sales service We are using the equipment Mispa Count of Agappe Diagnostics since last 18 months and we are satisfied with the results. We also have been using Agappe’s biochemistry reagents like Glucose, Cholesterol, HDL, Triglycerides etc. for the last three years. We would like to inform that the after-sales service of Mispa care is really great. Atul Y Chaudhari, Shreeram Clinical Laboratory, Jamner Maharashtra

to operate anywhere, including off the grid, allowing it to be independent of the complex and costly infrastructure required by IFV programs in the developed world. The system uses low-cost components, does not require complex microprocessorcontrolled incubators, and is a closed system that generates its own unique atmospheric and culture conditions required for normal fertilization and embryogenesis using inexpensive, common chemicals. The low-cost culture system is based on an incubator system consisting of two sealed glass tubes. A chemical reaction initiated by combining baking soda and citric acid in the first sealed glass tube generates an atmosphere that includes a specific percentage of carbon dioxide. The atmosphere is then transferred into the second glass tube holding the culture medium. The connection between the two glass tubes—needles and tubing—can easily be removed once the equilibrium between the two glass tubes is achieved. Oocytes and sperm are then injected by syringe into the tube containing the culture medium without disturbing the air environment inside the tube.

The road ahead Worldwide, more than 80 million couples suffer from infertility, the majority being citizens of the developing economies. In the developing societies, childlessness is often highly stigmatized and leads to profound social suffering for infertile women in particular, yet most infertile people in the developing world have virtually no access to any effective treatment. Bilateral tubal blocks due to sexually transmitted diseases and pregnancy-related infections is the most common cause of infertility in the developing countries, a condition that is potentially treatable with ARTs. New reproductive technologies are either unavailable or very costly in the developing countries due to private monopoly. Guidelines in the successful implementation of infertility care in low-resource areas include simplification of ART procedures like adopting IVF Lite, minimizing the complication rate of procedures like elimination of OHSS, providing training courses for health care workers and incorporating infertility treatment into sexual and reproductive health care programs. One of the United Nation’s Millennium Development Goals was for universal access to reproductive health care by 2015, and WHO has recommended that infertility be considered a global health problem, and stated the need for adaptation of assisted reproduction technology in low-resource countries.

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Life Story Harsha Shah

THE UNIQUE STORY OF AN IVF BORN WOMAN

CONCEIVING NATURALLY

Harsha Shah’s story is so unique in the sense that she is the first IVF born woman in India to conceive naturally. This happened at a time when many couples were worried whether the baby born through IVF will be able to conceive naturally.” Harsha’s case is a proof that babies born through IVF are as normal as any other child”, says Dr. Indira Hinduja who took the deliveries of both Harsha and her mother.

Harsha Chawda was the first scientifically docu-

mented in vitro fertilisation (IVF) baby in India. Now, she is a mother of two and leading a normal life. Harsha is also the first IVF born woman in India to conceive naturally. Another notable thing is that it was Dr Indira Hinduja who had taken the delivery of Harsha’s mother Mani Chawda was the one who took the delivery of Harsha too. “It was a proof that IVF babies lead a normal life,” Dr Indira said after delivering Harsha’s child safely. “To watch Harsha grow up, marry… she now has two children, a boy and a girl. The whole experience has been incredible and I’m A caring mother, Harsha, 34, is now busy looking after her two kids. Her son is five years old while her daughter is three years old. She is married to Divyapal Shah from Mumbai. Prior to it, she worked as a corporate secretary for a while in Mumbai. Her memory of being a ‘test-tube baby’ was filled with her hype in the media. “Every year they would throng our house to take photographs of me on my birthday. It was from them I first heard the word test-tube baby,” says she.

Looking Back

It really didn’t bother her at first. However when she grew up and began using test tubes in the science lab at school, she wondered what it was all about. “I associated test tubes with experiments and wondered if I was one too. I was very upset,” recalls her. Since, her parents were also helpless and unable to explain it to her, they called Dr Indira and that was how Harsha got to know about test tube babies while she was a teen. “Ever since that, we kept in touch over the years. When it was time for me to have my own babies delivered, we hadn’t thought of anyone else. She’s like my Godmother,” says Harsha on choosing Dr Indira for her delivery.

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Harsha took her graduation in Commerce from Mumbai University and found a job soon. Her father Shyam who had been a BMC worker passed away in 2003. She has single handedly managed the household after her father passed away. Looking back, she recalls how hard it was to survive. She complains that she received no assistance from the government, despite the fact that her birth had been hailed a medical marvel. Harsha even lost her job when she was hospitalised for a few days following an illness. Luckily, she was able to find another job. Harsha who married Divyapal Shah in 2015 got introduced to him through Pratiksha, his sister. Prior to it, Harsha — originally a Kathiawadi Gujarati — accepted Jainism as her religion. “On our marriage day, a lot of people were discussing that she was a test-tube baby. I was surprised to know that a lot

family said that it was indeed a gift from God. “I’m God’s gift and I believe my baby is also special. My baby is a blessing for me and there are no words to explain what I feel at this moment,” said Harsha after her delivery. A pioneer in assisted reproduction technology in the country, Dr Ind ira said Harsha’s delivery was significant and encouraging for couples looking to try in vitro fertilization (IVF) for conceivDr. Indira Hinduja holding Harsha’s baby with Harsha and her husband ing. “Many couples are worInset: Dr. Ind ira Hinduja holding Harsha immediately after her birth ried whether the baby born through IVF will be able to conceive naturally. Harsha’s baby of people had read about her,” Divyapal Shah said. “IVF proceis a proof that babies born through IVF are as normal as any dures were considered a taboo several years ago and it was a topic other child,” said the doctor who runs a fertility clinic at a of discussion in society. That is changing now,” he added. private hospital in Mahim. It was in March 2016, Harsha gave birth to a baby boy under the Proud Moment for IVF Team care of Dr Indira and Dr Kusum Zaveri. The doctor duo team took the delivery of Harsha when Harsha’s mother, Mani Chawda conHarsha’s successful conceiving of the baby naturally and ceived her through IVF procedure, thirty years ago. Harsha’s child delivery made doctors happy as it was the proof that IVF people weighed 3.1 kg and was delivered through a caesarean section at can lead a normal life and conceive naturally. Her husband Jaslok Hospital in Mumbai. They opted for C-section because it Divyapal Shah also reflected same joy after the delivery of his indicated a breach presentation. Although Harsha was born with wife. “Our son’s birth was a natural fact. We had planned this the aid of assisted reproduction technology (IVF), Harsha’s pregbaby. We didn’t have any apprehensions about Harsha or the nancy was conceived naturally. baby. We are a normal family and I am as happy as any father in the world would be,” said the businessman from Matunga. The baby was born on the auspicious day of Shivratri. Her

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Life Story Harsha Shah For Dr Indira, Harsha’s birth remains to be the most memorable event in her medical profession and the two share a special bond. “Coincidentally, Maniben’s pregnancy test came positive on my birthday. There was an international conference going on at King Edward Memorial Hospital, Mumbai (KEM) and a senior doctor interrupted it to announce the big news of the pregnancy,” she recalled. The doctor also blessed Harsha at her wedding in May 2015. Dr Indira adds: “The one thing I’m really proud is that I hadn’t acquired any special training from abroad for IVF in the 80’s. We had limited knowledge even on the surgical instruments required for IVF treatment. But gradually, we learned everything. People told me that I should be in the Guinness Book for taking the delivery of first IVF baby Harsha in India and then years later for assisting the delivery of that baby Harsha (now 34). I’m proud to have done my work with limited resources and training. Today, couples are more aware and knowledgeable. They decide at what stage in their life they’d like a child. The success rate in IVF has increased too.” Dr Indira said it felt like life has come a full circle for her team. “I remember the day Harsha was born. Her parents were on top of the world and so were we. It is hard to believe that we have delivered more than 15,000 test-tube babies since that day. Now Harsha’s child’s delivery was also done by us,” said the doctor.

The Story of Harsha’s Birth The couple Mani Chawda and Shyam had been trying to

Dr Indira said it felt like life has come a full circle for her team. “I remember the day Harsha was born. Her parents were on top of the world and so were we. It is hard to believe that we have delivered more than 15,000 test-tube babies since that day. Now Harsha’s child’s delivery was also done by us,” said the doctor. have a baby for four years after their marriage. She was a parttime teacher while her husband was a BMC worker. They had little knowledge about in vitro fertilisation (IVF). “They used to draw a chart to explain the entire process to us. But we couldn’t understand it much,” recalls Mani. They were willing to try anything to have the baby. “I had been married for five years, but didn’t conceive. That’s when my family doctor referred me to Dr Indira Hinduja. He even showed me an article in a Gujarati magazine on children born with assisted reproduction techniques. I visited Dr Indira then,” recalls Mani Chawda, now a grandmother. The medical procedure cost her Rs.20,000. Since her husband was a BMC worker, much of the medical treatment was free for them at KEM Hospital, Mumbai. They borrowed money to pay for the hormone injections. On the other hand, Dr Indira had attempted with IVF with 17 couples before she met them. However Mani Chawda’s turned successful in the first attempt itself. They had found out that Mani Chawda’s fallopian tubes had been damaged due to tuberculosis infection and subsequent surgery. In the scientific documentation provided by Dr Ind ira, it reads: “For in-vitro fertilisation, we needed that the ovaries should release more than one egg. Hence, the ovaries were stimulated by giving Oral medication namely, (Clomiphene citrate 100mg) from Day 3 to Day 7 of her menstrual cycle”. “The oral medication was supported by administering injection Human menopausal gonadotropin which was also given intramuscular daily from Day 5 to Day 10 of the cycle in a dose of 75 IU per day. The num-

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Testimonials ber and size of growing follicles was monitored by doing transabdominal sonography. The growth of these follicles suggested that multiple eggs were maturing in the ovary. We correlated this with blood estradiol levels which is a hormone released by the growing follicles. An increase in the level of this hormone levels mean that ovaries are responding to the treatment and the eggs were growing. In this manner we were able to see at least four growing follicles in each of the ovaries of the patient”, the document adds. “When the follicles were adequately grown, then injection Human Chorionic gonadotropin (hCG) 10,000 IU was administered to the patient on Day 13 to mature the egg within the follicle. This was in order to make the egg the ready for fertilisation. Thirty four hours after hCG, the eggs were retrieved. Using an abdominal approach, the ovaries were seen and a needle was inserted in each follicle to remove the fluid collected in the follicles. This fluid was screened under microscope for presence of oocytes / eggs. In this way we found 5 mature eggs and 3 immature eggs”, the document explains. Simultaneously the semen of the husband was taken, washed and centrifuged. This helped the team to isolate the best and most rapidly motile sperm from the sample for fertilisation. The eggs that were retrieved were combined in a laboratory dish with her husband’s sperm. The eggs were seen After 24 hrs for penetration of sperm in egg. After 48 hours and 72 hours for further growth i.e. 2-4 cell and 6-8 cells. On November 30 1985, the team transferred the embryos into the patient Mani Chawda’s uterus. On December 18 we did BhCG testing which indicated a positive pregnancy test and subsequently confirmed the pregnancy by redoing the BhCG test on 26 December 1985. Ultrasound was done on January 6, 1986 which showed a healthy growing pregnancy.” “It was a confusing time for us too. Once I missed one injection and Dr Indira scolded me so much. I also took part in a running race held on Sports Day at my school of which the doctor wasn’t much happy about. The media also turned up during the baby shower which created so much havoc,” recalls Mani. Later on August 6, 1986, she delivered the city’s first and country’s second test-tube baby, named Harsha at 4.10 pm. A neonatologist used to regularly check Harsha’s growth parameters to ensure that she was a healthy baby who grew normally like other babies. As she was the city’s first IVF baby, they ensured she hadn’t any growth abnormalities or congenital defects to her.

Business Partner

AGAPPE PRODUCTS CONTINUE TO EVOLVE WITH DENKA SEIKEN CO., LTD. Keisuke Miyazaki, International Sales Manager, Denka Seiken Co., Ltd

My name is Keisuke Miyazaki. I am an international sales man-

ager at DENKA SEIKEN CO., LTD. which is a publicly traded biomedical company founded in 1950 with its head office in Tokyo, Japan and manufacturing facilities in Niigata, Japan. We develop, manufacture and distribute high quality in vitro diagnostic reagents. Top export products include latex-enhanced serum protein tests for hsCRP, rheumatoid factor, myglobin, ferritin and others. DENKA SEIKEN possesses numerous collaborative business relations with worldwide diagnostic companies, and has ISO13485 and ISO14001 certification as well as a number of products FDA-cleared for sale in the US. More recently, the company has focused on contract R&D and manufacturing for immunochemistry products. India is unknown market for us. However, AGAPPE leads us to the best way for expanding the business in India. We work with AGAPPE together for 17 years. And AGAPPE is our best business partner we can trust. At the beginning of the business, we have supplied only few immunochemistry reagents to AGAPPE. However, we currently supply much more reagents to AGAPPE as the company size of AGAPPE expands. We just have started to supply AGAPPE the new immunochemistry reagent for H. pylori (Helicobacter pylori) which is a type of bacteria. H. pylori colonizes in human gastric mucosa and causes chronic gastritis. It is well established that progression of inflammation leads to gastric mucosal atrophy and gastric cancer. The International Agency for Research on Cancer has recognized that H. pylori is a cause of gastric cancer and that eradication of H.pylori is a preventive measure for gastric cancer. We believe that AGAPPE is only one company who sells the H. pylori reagent for the use of Clinical Chemistry analyzers in India. The H. pylori reagent from AGAPPE leads people to have a well health and good life. AGAPPE products continue to evolve with DENKA SEIKEN CO., LTD.

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Interview Pushpagiri Hospital

PUSHPAGIRI HOSPITAL EPITOME OF QUALITY HEALTHCARE

With more than 60 years of glorious tradition in offering healthcare services to the people of Kerala, Pushpagiri group of Medical institutions situated at Thiruvalla, in Pathnamthitta district of the south Indian state of Kerala stands tall among the top healthcare providers of Kerala. Over the years, Pushapagiri has emerged as an epitome of quality healthcare and medical education in south India

Technology Institute was started.

During that time, there was nothing to boast off at this eight bed clinic other than the service mentality and care provided by the staff and priests. The small clinic gradually grew into a General Hospital during 1980’s and later into a Super-speciality Hospital during the 90’s. From 1964 itself School of Nursing has been part of Pushpagiri Hospital. In 1980’s Medical Lab

With a view to spur this humble institution’s growth in to the diverse spectrum of healthcare, the first step was to spread its wings into the highly prospective field of medical education field leading to the establishment of the Pushpagiri Medical Society in 1992. Later it was registered as a Charitable Society under the Travancore Cochin Literacy Scientific & Charitable Societies Registration Act of 1995. In 2001, the hospital was elevated to the status of a medical college hospital. Continuing its expansion mode, today, Pushpagiri Medical College Hospital is on the errand of continuously scaling in health care sector and now has strength of 900 beds.

ushpagiri group of medical institutions is named after its Patron Saint ‘St Therese of Lisieux’, popularly known as ‘Little Flower’. Established in 1959 by Zacharia Mar Athanasios, the Bishop of the Malankara Catholic Diocese of Thiruvalla, the primary aim was to provide maternity and paediatric care to the rural people in and around Thiruvalla.

Full-fledged Healthcare Hub Pushpagiri Medical College Hospital is now in the forefront of healthcare providers offering care and treatment in various departments like critical care, emergency medicine, obstetrics and gynaecology, ophthalmology, orthopaedics, physical medicine, psychiatry, general surgery, general med icine, ENT, dentistry, paediatric, pulmonary medicine, dermatology, rad io d iagnosis, anaesthesiology. Apart from these, the centres of excellence at

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Pushpagiri Medical College Hospital in cardiology, cardiovascular surgery, urology, endocrinology, neonatology, nephrology, plastic & cosmetic surgery, neurosurgery, neuromedicine, paediatric surgery, gastroenterology, surgical gastroenterology, maxillo facial surgery, medical oncology, surgical oncology and rheumatology are used by patients from all over Kerala and outside. Non clinical departments like forensic medicine, physiology, pharmacology, anatomy and community medicine and Para clinical departments of immuno-haematology & blood transfusion medicine, biochemistry, microbiology and pathology are also among the specialities at Pushpagiri Medical College Hospital. “Due to the blessings of the Lord and especially through the intercession of the Blessed Mother and St Therese of Lisieux and through the hard work of the priests and doctors and nurses and other staff, Pushpagiri has grown to be one of the best medical institutes in Kerala. Recently our institute bagged the 10th position in health research in the world in the field of Endocrinology. Pushpagiri Medical College Hospital is one of the premier institutions of the Syro-Malankara Catholic Church and is committed to health care with uncompromising services and medical education and training of health personnel with quality and commitment, who are ethically upright and scientifically motivated,” says Rev Fr Jose Kallumalickal, Chief Executive Officer, Pushpagiri Group of Institutions.

Institutions for Diverse Needs Now, there are several institutions attached to Pushpagiri Medical College Hospital. Pushpagiri Institute of Medical Sciences, Pushpagiri College of Dental Sciences, Pushpagiri College of Pharmacy, Pushpagiri College of Nursing, Pushpagiri College of Allied Health Sciences, Pushpagiri Centre for Overseas Career Training, Pushpagiri Research Centre and Pushpagiri Centre for Virology are few of them. “All institutions are separate legal entities and are recognised by the respective councils. The institutions are under the single umbrella; Pushpagiri Medical Society, which is a registered charitable society. There are separate Directors and Principals for each institution. Pushpagiri College of Dental Sciences and Pushpagiri College of Pharmacy are located in a separate campus at

"The management is proud of Agappe’s achievements in a short span of time. They hope that Agappe’s indigenous products will help charitable hospitals like Pushpagiri to serve their patients with great products and services at affordable price".

Rev. Fr. Jose Kallumalickal Perumthuruthy, The Pushpagiri Medicity,” says Rev Fr Thomas Pariyarath, Hospital Administrator and Director IT, Pushpagiri Medical College Hospital. “Pushpagiri Hospital is the teaching institute. There is a separate Administrative and Financial control which is functioning under a centralised control. Auditing including internal audit and statutory audit enhances the efficiency of the institutions. The books of accounts have separate schedules for each institution,” says Fr Jose Kallumalickal.

Focus on Research and Innovation Talking about Pushpagiri Research Centre, Fr Kallumalickal added that the management realised that providing exemplary healthcare services and setting up educational institutions were not enough. Healthcare and field of education needs constant updating and innovation. Hence, research becomes an integral part for further scientific studies, discoveries and breakthroughs in health care. And these ideas again need to be conveyed through education. In short, Health Care – Education Research becomes a never-ending cycle in the mission of Pushpagiri. As a result, Pushpagiri Research Centre was set up in the year 2010. A diverse range of research activities are being undertaken by the research team, constantly triggered by the need for providing quality services for successful affordable health care services and products. Owing to the frequent outbreak of fatal viral diseases in Kerala during monsoons, the need for setting up a centre for diagnostics and studies of

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Interview Pushpagiri Hospital virus research became inevitable. Taking up this cause passionately, the Pushpagiri Centre for Virology, the only active, fully fledged facility of such a kind in Kerala, started in 2011. In November, last year Pushpagiri also made headlines with a first of its kind rehabilitation centre in the state to guide cardiac patients back to health. Pushpagiri Heart Institute at the Pushpagiri Medical College complex in Thiruvalla started the State’s first dedicated cardiac rehabilitation centre atRev. Fr. Thomas Pariyarath discussing about Pushpagiri Hospital with tached to a heart hosSunil M. Varghese, Regional Manager, Agappe pital. Ensuring that care count Treatment Programme and KASP, Karunya, ECHS for the is extended beyond the hospital, cardiac rehabilitation involves economically backward patients at Pushpagiri Medical College educating the patient about his or her heart condition, and ways Hospital. to manage it in the best possible way through structured exercise. Through this program cardiac therapists closely monitor The social commitment arm is extended to the staff at and guide the patient throughout the rehabilitation process Pushpagiri through various schemes. Pushpagiri Staff Conceswhich may extend up to two months. The rehabilitation centre sion Scheme provides concessional medical treatment scheme has been designed to monitor the response of the patient’s to staff, dependents and first degree relatives. Pushpagiri Staff heart to various exercises. Welfare Association on the other hand provides assistance for staff in house construction & maintenance, marriage, funeral and Always committed to the people scholarships and awards to children. Pushpagiri Medical College Hospital extends free and Pushpagir Medical College Hospital also made news when it subsidised medical treatment to the economically poor padonated two acres of prime land in the heart of Thiruvalla town tients in the society through various projects. Karuthal is a free for free for the construction of Thiruvalla Municpal Stadium. For medical treatment project of Pushpagiri Medical Society. UnThiruvalla Bypass, the management provided land at a nominal der this project, they were able to raise funds of more than Ten rate. Apart from all this, Pushpagiri also plays a collaborative role Crore Fifty Lakhs so far. There is also Pushpagiri Deep Disin disaster management with special emphasis to rehabilitation of the affected people.

“A charitable hospital like Pushpagiri is proud of being part of their global associations. Now we are looking to install their new innovation “Mispa Label” Intelligent Tube Labelling system for avoiding pre analytical errors. We wish all very success to Agappe to continue their efforts in helping mankind”.

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Upcoming projects The management of Pushpagiri is planning several projects for the betterment of patients from all over the state and people around the locality. “Several projects are in pipeline with a vision to extend world class care and treatment facilities at the hospital for patients. The renovation project of Pushpagiri Medical College Hospital is one such. The work will commence shortly. Apart from it, Pushpagiri Oncology Centre is another thing we are pursuing now. By mid-year, we will be able to put Pushpagiri Geriatric Care Centre functioning. These are our short term plans. However our long term goal is to turn Pushpagiri Institute to Pushpagiri University,” says Fr Thomas Pariyarath.

ASSOCIATION OF PUSHPAGIRI HOSPITAL WITH AGAPPE

The staff at the lab in Pushpagiri Medical College Hospital re-

called how Biolis 24i from Agappe had been helping them. “Since the inception of Biolis 24i, around one and half decades ago, we have been dealing with Agappe with utmost confidence. At the time of thinking an advanced system replacing Biolis 24i, there was no scope of rethought for changing the company. The quality of testing results and service support provided by team Agappe through Biolis 24i could easily help us to keep them with us in replacement process with TBA 120 FR many years back and still we enjoy its quality aspects,” says the lab technician. The management is also happy with the reagent quality which is quite evident in their words. “We are proud to announce that the quality of the reagents is at par with international standards at very affordable rate. At present, we relish their team Mispa Care’s service, therefore no day was in our list with a machine shut down,” says Fr. Kallumalickal. The management has also re-

Long term association with Agappe Pushpagiri Medical College Hospital has a long term relationship with Agappe. The management extended their gratitude for the warm hearted support provided by Agappe to the hospital. Recognising the contributions and investments made by Agappe in Indian IVD industry, the management believes that it is the right

called how Agappe had helped them with the contribution of a product. Agappe’s prestigious Semi Auto Analyzer “Mispa Viva” was provided free of cost to Pushpagiri Medical College Hospital’s satellite centrePayippad Hospital. They lauded the quality of “Mispa Viva”. The management is proud of Agappe’s achievements in a short span of time. They hope that Agappe’s indigenous products will help charitable hospitals like Pushpagiri to serve their patients with great products and services at affordable price. “A charitable hospital like Pushpagiri is proud of being part of their global associations. Now we are looking to install their new innovation “Mispa Label” Intelligent Tube Labelling system for avoiding pre analytical errors. We wish all very success to Agappe to continue their efforts in helping mankind,” he adds. model that should be developed. They hope indigenous products like that of Agappe will help to avoid the over dependency on multinational company products. “Agappe has come out with solutions and those solutions are much cheaper than many of the other products that we get from elsewhere. We think this kind of model needs to be expanded and a lot more companies should come to this field,” says Fr Thomas Pariyarath. He also noted how Pushpagiri and Agappe share similar thoughts of indigenous production helping the nation. “If knowledge creation is the main output of research activities, then health care in countries like India will become indigenous and affordable through science and technology, which in turn, will develop new processes and products. In its way forward, Pushpagiri believes that the future of India depends on the quality of health of its millions of people and in the creation of a significant number of knowledge workers – both constantly facilitated by research in health care,” he added.

Pushpagiri hospital, where quality treatment is assured as per international standards use only high quality equipment and reagents for IVD testing. Agappe’s support through TBA 120FR, we provide error free works. We are very much impressed with its quality results and its performance. Sister Maggy, Lab Coordinator, Pushapagiri Hospital

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Cover Story

Infertility Specific Distress

IN CYCLES OF DREAMS AND DESPERATION A REVIEW ON INFERTILITY SPECIFIC DISTRESS

Dr. Pratap Kumar Narayan, Professor, Department of Obstetrics & Gynaecology, KMC, Manipal

“Emotional distress in infertility” is a broad expression that loosely denotes anxiety, depression, grief, crisis, depleting psychological well being, and all forms of affective and interpersonal disturbances faced by individuals with infertility. The distress is usually associated with involuntary childlessness as it is an unwelcoming event. The developmental crisis associated with childlessness poses a threat to one’s sense of self at all levels (individual, family and social). Distress may begin before or during treatments as a person experiences the loss of control over attaining parenthood, anxiety or dejection after the diagnosis, treatments, its complications particularly its limited success rates.

Infertility Specific Distress Infertility specific distress refers to the degree of emotional strain associated with failure to conceive or experience childbirth. It has been identified as an important outcome variable in most of the evidence based data across many countries. It is also known to vary with time and phases of fertility treatments. Studies have identified that there are

two major sources of infertility distress. First of all, since most societies recognize mothering and fathering as essential social roles, infertility leads to an unexpected role loss (identified parent role, social role, biological role, and relational role). Second, as the treatment regimens, timings, strict scheduling coincides with the female partner’s monthly menstrual cycles, every cycle brings in cyclic reactions of hopes, and despair. The paper is divided into two sections, out of which the first part elaborates the basic concepts and theoretical models related to infertility distress. The section of this article highlights the gender differences in experience of infertility and effects of individual and treatment specific variables on distress. Each section lays a special importance on findings gathered from the national and international research.

Nature of infertility specific distress Infertility diagnosis becomes sources of chronic distress to both genders leading to emotional suffering in five major domains of daily life namely social, sexual, relational, needs for parenthood, and rejection of child free life. Literature on psychology of infertility does not delineate between psychological

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milieu. Research from the Indian database reports that infertility is impacted several domains of daily life and is thus experienced as a major stressor. The constellation of psychological reactions in infertility can be summarized as per seven major infertility specific frameworks elaborated below.

Theoretical Frameworks on Infertility Specific Distress Grief and bereavement approaches: Infertility involves the couple’s shared loss. Loss is many sided such as the loss of a biological role, physical and mental well being, parenting ambitions, life goals, self confidence, body esteem, control over one’s body, social status, social role, and parenting role. Often women are reported to mourn more openly than men. The “28 day grief cycle of infertility” describes the five stages of grief in women subsumed under the 28 days of the menstrual period. This grief becomes cyclic for couples with infertility and periodically remerges and it does not end until they experience childbirth or renounce the desire for a child.

consequences of infertility and consequences of infertility treatment as they are difficult to disentangle from each other. Most of the evidence based research emerges from clinic based data (available from high resource countries) that primarily focused on treatment related emotional stress.

Variability in infertility distress Data from 25 population surveys and sampling over a lakh infertile woman highlight that there are striking similarities in the trend of females seeking fertility treatments across less and more developed nations. Nonetheless, evidences support that the experiences of all individuals facing infertility are dissimilar in nature. There are studies that urge that almost 50% of women and 90% of men were minimally or moderately distressed, and about a 20%–40% of patients are highly distressed. It is also reported that before treatments and in the initial years, most of the sub fertile couples may not have any significant psychopathology. Nevertheless, a small subgroup among these do require psychological help. Despite high pre-treatment variability in infertile couples, when the same couples enter the treatment phase, these differences begin to blur. During treatments, emotional distress increases from the level initially reported by couples. Within a specific treatment module (intrauterine insemination [IUI], in vitro fertilization [IVF] embryo transfer, intracytoplasmic sperm injection [ICSI], Donor program), most patients present with more or less similar psychological profiles. Distress increases after treatment failures. Consequently, over a period, distress interacts with several other variables that cause a change in its course and magnitude. Pattern of variability in infertility distress can be explained by a plethora of factors present in one’s cultural and sociocultural

Ind ividual identity approaches: Children are viewed as an extension of oneself and one’s family lineage. From these perspectives, infertility causes a blow to one’s self concept, self image leading to narcissistic self injury. Stress and coping theories: The self regulatory perspective integrates the roles of cognitive representations, health beliefs, emotional representations in infertility. The uncontrollability, ambiguity, and uncertainty associated with this medical condition are significant which explains why for a majority of patients, infertility turns into an unbearable stressor. Social construction perspectives: Infertility may also be a stigmatizing and shame laden experience. Infertile men and women are perceived by others to be ‘defective and socially deviant’, adding to their feelings of guilt and inferiority.

Infertility involves the couple’s shared loss. Loss is many sided such as the loss of a biological role, physical and mental well being, parenting ambitions, life goals, self confidence, body esteem, control over one’s body, social status, social role, and parenting role.

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Cover Story

Infertility Specific Distress

Family systems approach: Infertility prevents family expansion, interrupts the normal role transition thereby blocking the progression of couples within their family life cycle. It can alter the existing dynamics, relations, boundaries, communication patterns, and tax the family’s coping resources.

Children are viewed as an extension of oneself and one’s family lineage. From these perspectives, infertility causes a blow to one’s self concept, self image leading to narcissistic self injury.

Phase or stage theory: This theory talks of the psychological struggles and adaptation of the couple from pre treatment to posttreatment stages. This model explains that there are five psychological phases of infertility through which couples progress. The Dawning of realization is the first phrase in which the couples begin to speculate that they have conception issues and seek a medical evaluation. Mobilization of psychological coping resources marks the next phase in which the couple is informed about the fertility problems, diagnosis, and given a prognostic plan. This is the stage in which coping resources need to be mobilized as adjustment problems emerge. Immersion is the next phase as the couple chooses and decides to begin treatments. It is the most complex and demanding phase. Resolution is the fourth phase for couples who do not conceive or experience childbirth. It consists of decisions on ending medical treatments, acknowledging, and mourning the loss of not having a child, and finally rethinking on alternative reproductive possibilities. In the end, the Legacy is the last stage that represents the aftermath of new and old unresolved psychological issues.

Gender Differences in Response to Infertility Response in women: Distress in women is higher than distress in men as historically the role of a female is considered to be more important in reproduction. Researchers explain that for women infertility is actually something that disturbs several aspects of her life for many years ahead. In most

Men maintain high secrecy, anger, denial, powerlessness, personal inadequacy, and sexual inferiority regarding not being able to live up to “the idealized masculine image of self.”

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of the developing countries, women are not only valued for their role in reproduction but are also blamed when they fail at living up to this role. This may be the reason why men and women differ in their experience of infertility and their response to same. Studies suggest that women report higher feelings of guilt, shame, grief, dejection of not being able to meet the standards of the “desired social role.” Women perceive infertility more negatively with greater intrusiveness of fertility related thoughts, goal blockage than their partners since they receive a more direct negative feedback about their fertility progress (negative pregnancy tests, menstruation, and physician’s feedback). Psychological adjustment in women is reported to be related to both their own goal appraisals (as well as their partners’) whereas in men, its related solely to their own goal appraisals. Another research conducted in women in India reveals that irrespective of the cause behind a couple’s childlessness, women by default carry a greater load of blame, responsibility, and guilt for reproductive failures. This is referred to “courtesy stigma” as a favor on the male partner to save him from the disgrace to his personal and his family reputation. Response in men: Men on the other hand have been less investigated on their desire for parenthood, reactions to failed treatments, long term adjustments and needs for medical support and structured psychological interventions. A recent systematic review of 92 studies on psychosocial aspects of infertility in men reveals that desires for parenthood, anxiety, and enduring sadness also prevails in men. Men maintain high secrecy, anger, denial, powerlessness, personal inadequacy, and sexual inferiority regarding not being able to live up to “the idealized masculine image of self.” Men report experiencing greater distress when a defect is identified in them, this is also true for pronatalistic societies. However, women experience infertility as a greater loss and have a stronger and an enduring negative reaction to it. Literature also suggests that men tend to underrate and women overrate infertility stress.

Distress in Men and Women Undergoing Fertility Treatments Literature reveals four major theoretical frameworks that have been used to describe the psychological response of individuals to infertility treatments. These are namely: (i) the psychological sequel approach, (ii) the cyclical approach, (iii) the outcome approach, and finally (iv) the context approach. The psychological outcome approach integrates the most recent biopsychosocial perspectives to clinical practice.

Effect of Individual specific Factors on Distress Psychological adjustment in infertility is affected by certain person centric variables such as the following.

treatments go at quite a length to achieve a childbirth rather than accept or adjust to involuntary childlessness. In addition to this, there are gaps in literature on the experiences of men resource constrained countries and its comparison with high income countries. Literature from Indian contexts depicts that women experience social hardships, personal and sexual inadequacy, low self esteem, guilt, shame, loss of body esteem, privacy, and integrity as a consequence of childlessness. In addition, fertility defines womanhood. Infertility is a highly stigmatizing condition. Thus, in order to break out of this stigma, women go through all kinds and any extent of fertility treatments.

Coping with infertility

Meta analytical reviews support that the infertility situation Personality factors: Personality characteristics predominantly is unpredictable and minimally controllable and a problem color emotional and behavioural responses. Data from a recent focused coping can lead to deleterious outcomes. Coping with systematic review suggests that neuroticism, trait anxiety, critiinfertility occurs at two levels, namely individual and at dyadic cism, sensitivity to stress, dependency, escapist coping, intrulevel. Gender wise differences are also evident. In addition to siveness, and anxious avoidant attachment style is correlated with this, short term coping is different from long term adaptation distress and low emotional adjustment. On the other hand, trait to infertility. As per the transactional theory of coping, indioptimism, resilience, well being, positive effect, and life satisfacviduals generally use distraction or avoidance to cope with low tion are associated with higher emotional adjustment. Studies control situations such as infertility. Limited distraction from suggest that cognitive appraisals (helplessness, hopelessness, ruminations or avoidance of anxiety provoking fertility situathreat, loss, and uncontrollability) and irrational parenthood cogtions is adaptive as it nitions are risk factors curtails short term for depression after treatment related distreatment failures. ProDistress in women is higher than distress in men as tress. However, overtective factors for dishistorically the role of a female is considered to be reliance on such tress are coping meastrategies in the long more important in reproduction. sures such as seeking inrun can lead to a reformation and positive coil effect. Within Inreattribution, compasdian contexts, limited sionate acceptance, cogstudies are available nitive appraisal, social on the coping patand spousal support, terns in infertility. open communication about the infertility Conclusion problem and developing Fertility treatan existential meaning ments are scientific out of the emotional exmarvels that began in perience. Career role sa1970s. With increasing lience, partner commurates of infertility, glonication and dyadic copbally, medically asing predicts social, persisted reproductive sonal, marital harmony, mindfulness acceptance and cognitive treatment and technology have become quite popular. Develdefusion, and alleviates stress. opments in these areas have also bloomed in our country siSociocultural factors: The importance given to â&#x20AC;&#x153;biological multaneously to its origins on other parts of the world. Over parenthoodâ&#x20AC;? can stir identity struggles and contribute to internal the past 50 years, most countries have come up with an eviand external shame in men and women experiencing infertility. In denced based committee report that elaborates clear guidedeveloping nations, fertility and childbirth are perceived as social lines on addressing psychosocial needs in infertility specific to responsibilities. Fertility treatments are thus quite popular as ineach phase of treatment. Systematic reviews and meta analytifertility is more of an unexpected life event and a major social cal evidences from the western contexts support that there issue rather than being just a medical disease. Despite the mediare personal, situational, and treatment related risk factors for cal, financial, and emotional costs, couples who can afford these infertility distress.

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Interview

Dr. Sonia Malik

POLYCYSTIC OVARIAN SYNDROME CLINICAL GUIDELINES FOR FERTILITY

Dr.Sonia Malik, Director-IVF, Max Smart Super Speciality Hospital, Delhi was the immediate past President of the Indian Fertility Society (IFS), Chair of the Infertility Committee of FOGSI, Chair of the Scientific Committee of IFFS 2016, Scientific Collaborator at the Reproductive Research Centre at the Cleveland Clinic (USA), Past President of the Indian Menopause Society and Co-Editor in Chief of the Journal of Midlife Health. Her areas of interest cover reproductive endocrinology, reproductive immunology, genital tuberculosis and premature ovarian failure. Excerpts from an interview with her about PCOS and its clinical guidelines over treatment protocols.

Techagappe: Dr Malik, you were the President of the In-

dian Fertility Society; please can you tell our readers a little about the work of the society & how you became involved in it? Dr. Malik: The Indian Fertility Society (IFS) was founded in 2005 with the intention of promoting academics and good clinical evidence-based practices among clinicians practicing in-

fertility management in India. Those were the formative years of infertility management in the country and there was neither any formal training available, nor practice guidelines. I am one of the founder members. It has taken us a decade to put things together because the country is large with lots of diversity. However, the society now has a truly national and international stature, with its own publications and training programs in the form of a newsletter and journal, a training program for embryologists and its own clinical fellowship. The society runs workshops, multicentric trials on different aspects of infertility across the country and as a distant learning initiative, have just incorporated webinars into the curriculum. We have taken a lead in the country by publishing the first practice guideline on the management of polycystic ovary syndrome (PCOS) in the country. The society is now poised to host the world congress of the International Federation of Fertility Societies in 2016. We are confident that we shall gradually be able to achieve the goals that we have set for ourselves. Techagappe : The IFS has recently published guidelines on polycystic ovary syndrome: what are the most important recommendations regarding diagnosis of PCOS? Dr. Malik: The Indian guidelines have been formulated using the Indian studies on the subject. We have observed that in the Indian context, both the Rotterdam and NIH criteria have been used in the studies, but the disorder has been better picked up using the Rotterdam criteria. The Indian phenotype also varies from region to region within the country. However, considering that majority of our population is rural and the doctors serving in these areas have minimal facilities, we have emphasized on ‘risk factors’ which should make the practitioner suspect the condition and enable him to refer to a higher center. The guidelines also take cognizance of the fact that Type II diabetes and metabolic syndrome are very common in the country – even in adolescents, hence need to be looked for while dealing with an Indian polycystic ovary patient. Also, we have tried to use the Indian published criteria

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from other societies in diagnosing PCOS â&#x20AC;&#x201C; for instance, the modified Ferrimanâ&#x20AC;&#x201C;Gallwey scale as recommended by the Indian Dermatology Association for the diagnosis of hirsutism. So, to summarize, the Indian guidelines recommend one clinical and one biochemical index as a risk factor for developing PCOS, especially in adolescents and such patients must be kept under surveillance or referred to a higher center for further evaluation.

POLYCYSTIC OVARIAN SYNDROME

Techagappe : And what about recommendations regard ing treatment of PCOS? Dr. Malik: The highlight of our guideline is that we have quoted and taken into consideration the Indian studies for each segment all through but also compared them with the International guidelines. And wherever we have not found robust evidence from our own studies, we have made standard recommendations from the other guidelines. Therefore, the recommendations regarding treatment are similar to those used in the other international guidelines. However, we have tried to define the maximum limit for the use of hormones as 2 years, especially in children and the elderly PCOS keeping in mind the high incidence of thrombophiliaâ&#x20AC;&#x2122;s in the country. A lot of emphasis has been given to diet and exercise. Techagappe : Are there any controversial sections to the guidelines? If so, why are they controversial? Dr. Malik: There are of course many controversies and challenges when dealing with a PCO patient. In fact, there are many questions that are still unanswered in this context. For instance, insulin resistance is the prime factor for the development of this disorder, but insulin measurement is not mandatory to make a diagnosis of PCOS. Similarly, the controversy of using metformin in pregnancy is addressed. Clinicians believe that it helps to prevent miscarriages, but evidence is lacking and none of the guidelines including ours recommends its use in pregnancy. Similarly, prescribing hormones for long may be harmful, as we have seen in the case of hormone replacement therapy in menopausal women. The question of when to start and when to stop hormone therapy in these patients is still a query. There is also the controversy of the thrombosis prone PCO. So, should all patients be screened for coagulopathies given that they must be prescribed hormone therapy for long duration? The question still is unanswered. Techagappe : What are the main challenges facing researchers in the PCOS field, & what about challenges for clinicians?

Dr. Malik: Evidence-based medicine demands randomized controlled trials to prove hypothesis and that is not always possible in human subjects. This is one of the biggest challenges. There are many grey areas in PCOS research and clinical application for this reason. Although a lot of clarity is now there as far as phenotypes are concerned, the biggest challenge is to find the exact cause for the disorder. It is also important to understand the evolution of the disorder. What exactly causes hyperinsulinemia and when it begins is not clearly understood. Research now points toward the origin in the prenatal period. The challenges therefore would be to define the pregnancy diet, lifestyle and drug interventions for women who are prone to or having PCOS in order that it is not passed on to the progeny. Similarly, infertility management though fairly stan-

Infection and inflammation is probably the most common but underdiagnosed part of infertility. Very little is known about the changes that come about as a result of these factors. Gene modulation as a result of inflammation is a cause for concern.

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Interview

Dr. Sonia Malik

dardized may not give the same success rates in all types of PCOS. Developing algorithms is a challenge since the exact cause and evolution of the syndrome is not very well known. Techagappe : How do you see the diagnosis & management of PCOS changing over the next 5â&#x20AC;&#x201C;10 years? Dr. Malik: This is a remarkable time for scientific research and advancements. In fact, the last two decades have changed scientific thought completely. With the advent of genetics and epigenetics, PCO research has a new dimension now. We are gradually becoming aware of the development of various phenotypes due to genetics, diet and environmental influences. Weight is supposedly one of the biggest influences in the development of the disorder and lifestyle and diet is the mainstay of management for this. A lot of research is going on to find the correct long-term diet for such patients. Bariatric surgery is also slowly gaining importance as a treatment modality in grossly obese PCOS patients. However, the long-term effects of bariatric surgery on the health and weight of the individual are still unknown. Recent developments in pharma cogenomics may provide clues to the relationship between response to drug therapy and the underlying individual genetic makeup. There is emerging evidence that women with PCOS exhibited a variable response to metformin based on the polymorphism in the STK11 gene. It is therefore a possibility that diagnosis and treatment protocols may be defined based on the genotype and phenotype of the patient. Presently, with the diagnostic criteria and guidelines now in place, many things are clear, but a lot needs to be done in order to bring uniformity in management among clinicians

Assisted reproduction technology has revolutionized reproductive medicine. With better understanding of the process at molecular level and a perfect blending of basic sciences and clinical application, management of infertility will change completely. from different specialities. Today, gynaecologists are looking at the d isorder d ifferently than the endocrinologists or the paediatricians. I am confident that in the coming years we will have dedicated PCOS clinics where all concerned clinicians would be working together. Techagappe : Are there any particularly exciting areas of research within the realm of womenâ&#x20AC;&#x2122;s fertility in general that you would like to discuss briefly? Dr. Malik: Infection and inflammation is probably the most common but underdiagnosed part of infertility. Very little is known about the changes that come about as a result of these factors. Gene modulation as a result of inflammation is a cause for concern. There is an urgent need to look into the immunology of infections and its impact on reproductive health. Chronic infections like genital tuberculosis are rampant in lesser-developed parts of the world and who knows they may be associated with hormone disorders like PCOS as well!

Endometriosis is another enigmatic disease of the disordered immune system causing infer tility that seems to be increasing due to stress and lifestyle.

Endometriosis is another enigmatic disease of the disordered immune system that seems to be increasing due to stress and lifestyle. Although infertility management in endometriosis is fairly well defined, there are still grey areas remaining. Oocyte quality, embryogenesis and quality and poor implantation are challenges. Many times, endometriosis and PCOS may co-exist leading to further complexities in management and outcomes. As we delve into the various fertility disorders, we seem to be realizing the important role of the immune system. Clinicians however are not very well versed with the nuances of the immune system hence more clinical research is required in this area for better reproductive outcome.

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CAUSES OF POLYCYSTIC OVARIAN SYNDROME The exact cause of PCOS is unknown, but it often runs in families. It's related to abnormal hormone levels in the body, including high levels of insulin. Insulin is a hormone that controls sugar levels in the body. Many women with PCOS are resistant to the action of insulin in their body and produce higher levels of insulin to overcome this. This contributes to the increased production and activity of hormones like testosterone. Being overweight or obese also increases the amount of insulin your body produces.

Treatment There's no cure for PCOS, but the symptoms can be treated. Speak to a GP if you think you may have the condiTechagappe : How do you see management of female infertility changing in general over the coming years? What are the main obstacles to overcome? Dr. Malik: Assisted reproduction technology has revolutionized reproductive medicine. With better understanding of the process at molecular level and a perfect blending of basic sciences and

With stem cells and gene therapy just round the corner, the need for third party reproduction should decrease. Pregnancy after uterine transplant is a reality now and in the coming years more such cases would be seen thus giving respite to those with uterine factor infertility.

tion. If you have PCOS and you're overweight, losing weight and eating a healthy, balanced diet can make some symptoms better. Medications are also available to treat symptoms such as excessive hair growth, irregular periods and fertility problems. If fertility medications are not effective, a simple surgical procedure called laparoscopic ovarian drilling (LOD) may be recommended. This involves using heat or a laser to destroy the tissue in the ovaries that's producing androgens, such as testosterone. With treatment, most women with PCOS are able to get pregnant. clinical application, management of infertility will change completely. Fertility preservation has already begun to change the infertility scenario. Treatment has now been extended to the fertile normal couples as well in the form of social oocyte freezing so that they can reproduce at will. This is also a boon for cancer patients. The newly discovered autologous mitochondrial transfer maybe a lease of life for patients suffering from premature ovarian aging. With stem cells and gene therapy just round the corner, the need for third party reproduction should decrease. Pregnancy after uterine transplant is a reality now and in the coming years more such cases would be seen thus giving respite to those with uterine factor infertility. More research is however needed to achieve excellence in this field before these can be clinically applied. Presently, the major obstacle is lack of self-regulation and ethical practices among the doctors due to which new innovations are immediately applied to patients without knowing the long-term repercussions of treatments. It may not be wise to apply all basic science research to clinical practice due to lack of experience with such practices. In our enthusiasm to better infertility outcomes we need to be cautious that we do no harm to the patient.

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Health Tips

INFERTILITY: A FEW TIPS FOR

A CONTENTED MARITAL LIFE Dr. C S Satheesh Kumar, Sr. Vice President-Supply Chain Management, AGAPPE., (Retd. Drugs Controller, Kerala)

Here are a few tips for those who are facing the vexed problem of infertility. We believe that these guidelines can help a lot in building hopes for a contented marital life for those who are affected. Infertility generally is interpreted as not being able to get pregUp to 15 percent of couples are infertile. This means they canâ&#x20AC;&#x2122;t nant after at least one year of trying. Female infertility can result from age, physical problems, hormone problems, and lifestyle or environmental factors. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Illnesses, injuries, chronic health problems, lifestyle choices and other factors can play a role in causing male infertility.

conceive a child. In over a third of these couples, male infertility plays a role. Second portion of one third is due to female issues, remaining third of the cases may be caused by a combination of male and female infertility, or they may have no known cause.

Common causes The most common causes of female infertility include problems with ovulation, damage to fallopian tubes or uterus, or problems with the cervix. A woman who has never been able to get pregnant will be diagnosed with primary infertility and who had at least one successful pregnancy in the past will be diagnosed with secondary infertility. Obesity, POCS (Polycystic ovarian syndrome), sedentary lifestyle etc affect the female sexual functioning very much. Obesity has a higher incidence of menstrual dysfunction and anovulation with high risk for reproductive health. The risk of fertility and conception rates, miscarriage rates, and pregnancy complications are increased in PCOS. It is one of the most common hormonal disorders in women of reproductive age, affecting 5 to 10 percent. Women with PCOS have irregular menstrual bleeding and often have difficulty getting pregnant. The syndrome occurs when levels of hormones are abnormal. Polycystic ovarian syndrome refers to the appearance of small cysts along the outer edge of the enlarged ovaries of women with this condition. Obesity and PCOS are mutually complementary, due to high glucose intolerance in PCOS patients. Eating a larger breakfast and smaller evening meal may help to improve hormone levels and regulate ovulation in women with PCOS. Adequate supply of healthy fats like omega-3 fatty acids can help reduce blood insulin and testosterone

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levels and improve insulin resistance. Similarly, a moderate reduction in carbs reduces insulin and testosterone levels, improving insulin sensitivity. It may also result in slightly greater weight loss. Regular exercise may improve insulin resistance and ovulation, help burn body fat and reduce inflammatory markers in women with PCOS. supplementing with 1,000 mcg of chromium and Vit D for two months helps in insulin sensitivity by up to 38% in obese women with PCOS.

Essential precautions during pregnancy

As a woman, it’s important to make healthy lifestyle choices during pregnancy. Smoking ages the ovaries and decreases your supply of eggs. It also harms your cervix and fallopian tubes and increases your risk of ectopic pregnancy and miscarriage. Obesity can harm your health in several ways, including interfering with your ovulation. Limit your caffeine intake to 200 mg per day, especially when you’re trying to conceive. That’s the equivalent of about two, eight-ounce cups of coffee per day. Unprotected sex, especially with multiple partners, increases your chances of getting sexually transmitted diseases which can permanently damage your fallopian tubes and uterus. Cigarette smoking interferes with the body’s ability to create oestrogen leading to ovulation failure, interfere with folliculogenesis, embryo transport, endometrial receptivity, endometrial angiogenesis, uterine blood flow and the uterine myometrium etc. Smoking reduces the chances of IVF producing a live birth by 34% and increases the risk of an IVF pregnancy miscarrying by 30%. Also, female smokers have an earlier onset of menopause by approximately 1–4 years as per reports.

Important diet tips

High-fibre vegetables, such as broccoli, cauliflower, and Brussels sprouts, lean protein, such as fish, anti-inflammatory foods and spices, such as turmeric and tomatoes, greens, including red leaf lettuce and arugula, with beans, lentils almonds, berries, sweet potatoes, pumpkin can help fighting PCOS. Flaxseeds and sesame seeds can do wonders for PCOD patients, with dose not more than 20 grams per day.

Try to have pre-natal vitamins, healthy foods, leafy green vegetables. Spinach, broccoli, fortified cereals, oranges and strawberries, beans and nuts, rich in antioxidants like folate and zinc. One should avoid food like high-mercury fish, soda, trans fats, high-glycemicindex foods, low-fat dairy, excess alcohol, soft cheeses etc.

Generally, infertility in men is due to the following like sperm count, shape of sperm, motility issues, older age, heavy smoking, heavy alcohol intake, consumption of pesticides, heavy metals, medical conditions, hormonal imbalance, exposure to radiations, chemotherapy, body building hormones. Smokers are 60% more likely to be infertile than non-smokers. Genetic variations like chromosomal abnormalities, mutation can interfere with fertility. One should avoid food like high-mercury fish, soda, trans fats, high-glycemic-index foods, low-fat dairy, excess alcohol, soft cheeses etc. Too much sugar can cause a whole host of problems including insulin resistance, weight gain, yeast infections, lowered immunity and hormone disruption. Since too much sugar can cause hormone disruption, it can interfere with our fertility. In fact, it can make us infertile, eating diets high in sugar affects all. Refined carbohydrates cause inflammation and exacerbate insulin resistance and should be avoided or limited significantly. These include highly processed foods, such as: white bread, muffins, breakfast pastries, sugary desserts, anything made with white flour. It’s a good to remove inflammationcausing foods, such as fries, margarine, and red or processed meats from our diet as well.

Physical fitness and lifestyle matters a lot Males also should lose weight. Since excess weight can cause hormone changes that reduce fertility. It is also linked to

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Health Tips

Yoga can do wonders

Yoga is a safe and magical alternative if you plan early in your life. Following Yoga postures are good enough for infertility.

Sarvang Asana (Shoulder stand): This is a tactful posture in which a person has to maintain his body balance while being upside down. The shoulder stand stimulates the thyroid glands and strengthens the entire body muscles. Hal Asana (Plough pose): Plough pose increases blood circulation to the pelvic area and enhances reproductive wellness. With regular practice, it can also help in increasing physical flexibility. Dhanur Asana (Bow pose): Dhanur asana helps to increase the blood flow to the reproductive organs and enhances sexual wellness in men. It also helps to combat erectile dysfunction and premature ejaculation, thereby enhancing fertility in men.

Pada Hasthasana (Standing forward bend): This asana stretches the spine, hips and legs. It enhances the blood circulation to the brain and brings equilibrium in the body. Bhujang Asana (Cobra Pose): Bhujang asana relieves the stress off the back muscles and spine. It enhances the wellness of the reproductive organs. Bhujang asana is a good exercise for keeping back pain and sprains at bay!

Nauka Asana (Boat pose): Boat pose makes the muscles of the legs, hips and abdomen stronger. It tones the pelvic muscles and helps Manage your stress. If you feel in releasing the sex horlike stress is affecting your mones. It can effectively shed the unwanted belly fat health or your relationship, as well, thereby, boosting consider talking to a licensed a person’s self- confidence. counsellor or psychologist

who can help you with coping strategies.

Kumbhak Asana (Plank pose): This seemingly easy yoga posture offers many benefits to the body. Plank pose strengthens the upper body and increases sexual stamina. It helps to increase a person’s fertility by enhancing his sexual wellness. Paschimottan Asana (Seated forward bend): Paschimottan asana helps to tone the muscles that support the reproductive organs. It has positive effects on the digestive system and the mental health of a person. With regular

Sethu Bandhasana (Supported Bridge pose): t brings blood to the pineal, pituitary, thyroid and adrenal glands, helping them work more efficiently and better reproductive stability.

Viparita Karani (Legs up the wall): t regulates blood flow, relieves swollen ankles and varicose veins and helps testicular, semen, and ovarian problems in men and women respectively. Balasana (Child’s pose): This can help alleviate stress and anxiety, flexes the body’s internal organs and keeps them supple, reduce stress, calm mind and body.

lower sperm counts and sperm that don’t move quickly enough. Don’t get overheated, especially around your scrotum, which can reduce sperm production. Limit your time in hot tubs and saunas.

benefit your overall health and wellness as well as your fertility. Tweak your diet to get adequate nutrition. Preparing more meals at home and adding more fresh fruits and vegetables, whole grains and lean protein to your diet are an easy place to start.

Avoid tight-fitting pants., tight under garments and placing your laptop computer directly on your lap during use. Bike riders on a synthetic hot seat can elevate groin temperature, turning harmful in long run. Take care of pain, swelling or a lump in the testicle area, recurrent respiratory infections, inability to smell, abnormal breast growth (gynecomastia), decreased facial or body hair or other signs of a chromosomal or hormonal abnormality. Exercise and sleep, reduce stress, have enough Vit D, ashwagandha etc help us in infertility

Manage your stress. If you feel like stress is affecting your health or your relationship, consider talking to a licensed counsellor or psychologist who can help you with coping strategies. You may also enjoy trying new activities that can help relieve stress, such as yoga, meditation or massage.

Couple together can make some lifestyle adjustments that

practice, it can treat erectile dysfunction as well.

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In fact, infertility is more of a condition and normal functioning of reproductive systems can be restored with proper exercise, yoga, food and lifestyle modification to a larger extent. Even in medical procedures also, lifestyle modification can synergise the effect very much.

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Cover Story Good Laboratory Practices

ALL ABOUT THE AUXILIARY

SOLUTIONS IN AUTOMATION Sanjaymon K R, General Manager, Business Development, AGAPPE

IVD sector is one of the segments in healthcare in which innovative solutions are introduced year on year. The goal of the laboratories today is to give accurate results at affordable cost in short time. Because of this there is huge growth in the installation of automated analytical systems annually. One of the other growth factors in this segment is the introduction of entry level compact tabletop automation systems in Clinical Chemistry and Immunology at affordable price. The other segment with an exponential growth in IVD is hematology, thanks to the local manufacturing. IVD sector is one of the segments in healthcare in which inno- equipped with software interface with Quality Control statistics

vative solutions are introduced year on year. The goal of the laboratories today is to give accurate results at affordable cost in short time. Because of this there is huge growth in the installation of automated analytical systems annually. One of the other growth factors in this segment is the introduction of entry level compact tabletop automation systems in Clinical Chemistry and Immunology at affordable price. The other segment with an exponential growth in IVD is hematology, thanks to the local manufacturing. Every laboratory is concerned about the quality of tests reported. The importance of internal Quality Controls, External Quality Assessments, Inter and Intra-laboratory testing etc are increasing day by day. The new generation systems are

to enable the shift and trends in the parameters tested. Even though the laboratories are taking utmost care in the analytical stage, there are some areas which once overlooked creates chaos in the routine working

Inlet water used for the automated system Majority of the laboratories today depends on fully automated platforms for their general testing. Most of these systems have onboard washing systems which require specific water flow ranging from less than three liters per hour to more than 40 liters per hour based on the throughput. The water is used by the system for internal cleaning of the probes (Sample or reagent), cuvettes and mixing unit. In general practice, the laboratories are using water treatment station or may buy the water in big container based on the daily requirement. All the instrument manufacturers give the specific requirement of the water quality to be used in the system. As per the guidelines, the water quality required for the clinical chemistry analyzer platform requires de-ionized water with a conductivity of 1.0 ÂľS/cm or less. The purity of water is very critical and may affect the tests like Calcium, Magnesium or even electrolytes estimation badly. The best way to control the quality of water is to test the conductivity regularly. Now the question is; are we testing the conductivity regularly? Let us take the case where the water from the treatment plant is directly

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connected to the analyzer. In such cases the water plant is made based on the input water quality and the out put of the water to the analyzer is based on the above assumption. Any change in the feed water quality to the water treatment plant may affect the input water quality to the analyzer. It is recommended to use an online water quality meter with buzzer to make sure that the input water quality to the analytical instrument is as per the requirements. For those customers using commercial water from containers it is recommended to check the quality using a handheld Conductivity meter before connecting the same to the analyzer. Please keep in mind that keeping the water for long time in cans can results in algal growth in the container. A visual check of the water can is also recommended. In case of systems connected with offline water can, the same needs to be cleaned periodically as per the manufacturer recommendation. Whether it is online connection or from water can, the laboratory should maintain an SOP and a logbook to make sure that the water quality is controlled properly.

The role of Auxiliary Detergents For the automated analyzers with onboard washing of cuvettes, specific auxiliary reagents or detergents are used to make sure that the cuvettes, probes or mixers are washed properly. The washing cycle includes removal of the reaction liquid from the cuvettes, washing the cuvettes with water, dispensing the different detergents into the cuvettes, removal of the detergents, washing with water, drying the cuvette and checking the quality of cuvette for next step. The washing steps may be different from instrument to instrument, but the overall process remains similar having the usage of detergents for cleaning the cuvettes. There are systems which uses only one type of detergents to systems with more than 3 types of detergents. These detergents are also used for minimizing the carryover which may arise from reagent or sample. In general, the detergents are provided in con-

It is the responsibility of the technical person concerned in the laboratory to make sure that the quality of water used in the system and the auxiliary reagents used are as per the recommended specification of the manufacturer.

It is recommended to use an online water quality meter with buzzer to make sure that the input water quality to the analytical instrument is as per the requirements. centrated form and are diluted using de-ionized water as per the recommended percentage which is specific to the instrument. Here the important factor to be noted is the dilution of the detergent. If the detergent is too strong, the detergent may not be removed properly during the instrument wash cycle and the remnants of the same will remain in the cuvette or probe creating carryover. If the detergent is too weak, the cuvettes may not be cleaned properly and will create reagent or sample carryover. It is always recommended to use measuring jar to dilute the detergents to maintain proper dilution of the detergent.

Types of detergents Majority of the instruments are having two types of detergents, one an alkaline detergent and the other an acidic detergent. The purpose of these two detergents is different and hence, the laboratories should make sure that the detergents are kept in the specific container to avoid improper washing. Since the detergents are slimy in nature, there is chance of getting turbidity in the detergentâ&#x20AC;&#x2122;s tanks over a period. It is recommended to clean the detergent tanks periodically to prevent the blockage of the inlet tubes. In analytical systems with onboard washing, quality of the results depends on the quality the cuvette. It is the responsibility of the technical person concerned in the laboratory to make sure that the quality of water used in the system and the auxiliary reagents used are as per the recommended specification of the manufacturer. Any deviation from the above may result in erratic results and even can create total shutdown of the analytical instrument. The laboratory should have periodic checking of the water treatment plant, cleaning of the detergent tanks and visual inspection of the cuvettes, probes and mixing station to make sure that the system is working as per the recommendation to have minimal down time of the analytical systems.

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Reliability Counts 60 reagent positions | Dual 5 speed rotating stirrers 8 step washing process | Emergency loading port 90 permanent pyrex cuvettes

Fully Automatic Random Access Clinical Chemistry Analyzer

â&#x20AC;&#x153;Agappe Hillsâ&#x20AC;?, Pattimattom (PO), Dist. Ernakulam, Kerala - 683 562, India. TEL: + 91 484 2867000 | productcorp@agappe.in | www.agappe.com

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Fully Automatic Random Access Clinical Chemistry Analyzer

“Agappe Hills”, Pattimattom (PO), Dist. Ernakulam, Kerala - 683 562, India. TEL: + 91 484 2867000 | productcorp@agappe.in | www.agappe.com

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Engagements Accolades

Agappe Diagnostics Ltd. has been awarded “Most Promising Company in Invitro Diagnostics”.

"Dear our well wishers, It gives us immense pleasure to inform you all that Agappe Diagnostics Ltd. has been awarded “Most Promising Company in Invitro Diagnostics”. The contestants were merited based on the profile, assessment of achievements and vision, comprehensive online research and customer reviews. The event was attended by the top IVD players with global presences. The prestigious memento and certificate was handed over to Mr. Thomas John (Managing Director), Mrs. Meena Thomas (Director) and Mr. Joseph John (Director) at the 10th MT India Healthcare Awards 2020 partnered with Messe Dusseldorf, Germany on 6th March 2020 at Goregaon Exhibition & Convention Centre, Mumbai". Team Agappe.

AGAPCON 2020 (Business Partner’s Meet - International) on 2nd February 2020 at Dubai

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Engagements Exhibitions

MORE PLACES TO KNOW ABOUT US MEDICONEX 2020 April 7th to 9th 2020* at Egypt International Exhibitions Center, Cairo (Egypt)

Team Agappe at Medlab Middle East, Dubai

Mediconex Exhibition and Congress is North Africa's largest healthcare exhibition and is a leading platform for the industry to meet, learn and do business. The exhibition takes place at the Egypt International Exhibition Center (EIEC), Cairo, and will attract more than 5,000 healthcare professionals and host 155 of the worldâ&#x20AC;&#x2122;s leading healthcare suppliers, manufacturers and service providers. After a somewhat challenging period in Egypt, the economy seems to be recovering and the market is experiencing sustainable growth predicted to reach a 5.6% increase by the end of 2019 making it a great location to gather regional medical professionals and businesses.

EXPOMED EURASIA 2020 Team Agappe at Medical fair India, Mumbai

Customer group meeting at Mandalay, Myanmar

June 11th to 13th 2020* at TUYAP Fair and Congress Center, Buyukcekmece, Turkey Agappe Hall No.3 | Stand No. 343B The expoMED Eurasia is an international exhibition for medical analysis, diagnosis, health care, hospital supplies and rehabilitation aids. It provides comprehensive information about new products, technological developments and conducted studies from the participant companies. The expoMED Eurasia is not only a commercial fair but also a platform for communications, information and cultural transfer and attracts visitors from Turkey and abroad. *Tentative dates due to COVID19

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Brand Reach Customer Speaks

WONDERFUL JOURNEY WITH AGAPPE Greetings, We have been associated with Agappe since last 8 years and it was been wonderful journey with Agappe team. They have taken us as family and provided us with immense support and helped us in growing in every possible way. Agappe has an excellent support staff with excellent services with some of the finest instruments to fit in all types of labs. I wish Agappe team all the best and success for all future endeavours as their success is our success and vice versa.

Dr. Yugam Chopra,

Director, Kos Diagnostic Lab, Ambala Cantt

IMPRESSED WITH ACCURATE RESUL TS RESULTS

Dr. Bela Sethi

Mispa instruments give accurate results inspite of compact size. We are using Mispa i2, Mispa i3 and I sens instruments . All of them are user friendly and give accurate results. The best part is that there is no hidden cost of extra sample cup,priming or maintai- nence of the instruments.

Lab Director, Nemcare Hospitals, Guwahati

INNO VATIVE RANGE OF PRODUCTS INNOVATIVE A very happy new year to Agappe, an Indian company which has given great competition to the other larger international players! And rightly so! Over the years, they have grown at an exponential rate to cover expansive, yet innovative range of products in the diagnostic market. However, our personal favorite point for this company is the relationship they share with their customers. Every Agappe employee in the hierarchy from the highest to the lowest, has always been forthcoming and enthusiastic in helping their customer. As a special mention, I'd like to appreciate the exceptional post sales services which they offer, which shows that they don't just sell their products, but nurture them even at client site, so that we, the client, are able to use the product to its full potential! As a customer, I feel Agappe and it's employees are our partners in helping our Laboratory grow!

3 Dr. Munjal Shah, MBBS, MD (Pathology)

Paras Pathology, Santacruz.

AGAPPE IS AL WAYS OUR FIRST CHOICE ALWAYS

4 IC Cherian,

Managing Director, Metro Scans, Trivandrum

TECHAGAPPE

We, Metro Scans & Laboratories is been associating with Agappe for last 15 years. We started our relationship with purchase of fully automated bio chemistry machine Biolis 24i and I am very proud to share that we are still using this machine at one of our branches. Agappe is always our first choice for any laboratory investment due to the trust built over the last several years of association. Agappe is a name which can be trusted for both high quality machineries and reagents. We wish Agappe all the success for its future ventures in this auspicious occasion of Silver jubilee Year.

APRIL - JUNE 2020

Reward Programme

CONSENT

By signing this form, I confirm that the information provided above is true and that I am fully familiar with and accept the General Business Terms for Privilege Account. I agree that the authorized personnel of Agappe Company may collect and process my personal information, the information about received privileges, collected points, information regarding the privileges used and other Information acquired during my visit to AG privilge website and ACEP mobile application. Also in absence of me I authorize my staff Mr / Mrs. / Miss / ………………………….........to avail benefits of AG Privilege and redeem Reward point's benefits using the registered mobile……………………………..... Number, through AG Privilege Website / AG Privilege mobile application. Also Agappe Diagnostics Ltd undertakes to handle the information in line with the requirements of the Personal Data Protection Act and that it will use them only for marketing reasons.

Proprietor Name:..................................................................................................................................................... Address..................................................................................................................................................................... .................................................................................................................................................................................... Date:

Disclaimer • AG Privilege points are subjected to offer made to Agappe Loyal customers who are either purchasing or using existing Agappe reagent as products.AG Privilege offers are not valid on instrument purchase. • Lab must claim points accrued through the program through the redemption process to exchange the points for reagents. • Lab must claim points or rewards only after reaching the redemption level. • Points can be claimed and used for rewards available in the then current program only and by authorized personnel of Laboratory. • Point requirements assigned to any reward are subject to change from time to time without notice, and rewards may be substituted at any time. • The loyalty points can be claimed by the Legal owner of the program and will be done only after

Sign & Seal of the owner / proprietor / director

Scan QR code to download AG Privilege app

submitting the signed copy of the disclaimer. • Agappe diagnostics/Agappe employee will not be in any manner responsible for any claim on account of claim/Point redeemed or point burnt by lab technicians/distributors, distributor staff or any other personnel who is not a part of lab or hold any organizational position. Any such act, if it comes to the notice, will be considered as malpractice and the concern laboratory owner/director or any other official will be informed. • Delivery of reagents will be done after conducting and possible due diligence. • Agappe require verification of lab identity and account prior to processing your order. • Government/Semi Government undertakings will not be covered under this program. • The Privilege program is not meant for any Agappe staff. • Jurisdiction: Any dispute arising out of this program shall be subject to the exclusive jurisdiction of the Courts at Ernakulam, Kerala, India.

Kindly fill the form carefully and hand over to Agappe’s staff or post to The Manager-Corporate Communication, Agappe Diagnostics Limited, Agappe Hills, Pattimattom PO, Ernakulam district, Kerala-683562. For more details, contact +91 9349011309.

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Editorial Feedback 1.……………………. is not used as an Iron status marker? a)Haematocrit

b)Prealbumin

c)Transferrin

2.High Ferritin test results reveals…………………………… a) Anemia

b) Kidney Disease

c )Arthritis

3. Pack size & Stability of Ferritin in Mispa i3 is ……………….. a)10 Test pack stable upto expiry c) 10 Test pack stable for 90 days

b) 30 Test pack stable upto expiry

4. Testing time for Ferritin in Mispa I series is …………….. a)10 minutes

b)5 minutes

C) 30 minutes

5. Ferritin values above 3000 ng/mL can be termed as…………...….. a) Still's disease

b) Hyperthyroidism

c) Liver disease

Scan QR code and participate in the lucky draw contest. Amazing prizes are waiting for the winners. Conditions apply*

Answers of this quiz contest will be published in the next edition along with details of the winner and the prize. Participants can either hand over the answers to Agappe’s staff or send in their responses directly to TechAgappe at techagappe@ agappe.in or post a mail to The Manager-Corporate Communication, Agappe Diagnostics Limited, Agappe Hills, Pattimattom PO, Ernakulam district, Kerala-683562.

What do you think of this edition of TechAgappe? Are you happy with the overall look and feel of the magazine? Do you recommend any change of style with regard to presentation of articles? You can share your views with us in the space given below. All you have to do is to post this sheet of paper to the address given below. The best letter shall be featured in the next edition’s letters to the editor section. ................................................................................................................................................................................ ................................................................................................................................................................................ ................................................................................................................................................................................ ................................................................................................................................................................................ ................................................................................................................................................................................ ................................................................................................................................................................................ ............................................................................................................................................................................... Name..................................................Address..................................................................................................... Pin....................................Mobile.............................................Email ...............................................................

Postal address:

The Manager - Corporate Communication, Agappe Diagnostics Limited, Agappe Hills, Pattimattom PO, Ernakulam district, Kerala-683562. Email: techagappe@agappe.in Mob: +91 9349011309

Kindly let us know which section of the magazine you like more... Poem Cover Stories

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Life Stories Good Laboratory Practices

Health Tips Interviews

We help Medical Fraternity to Diagnose...

CORPORATE OFFICE Agappe Hills, Pattimattom P.O, Dist. Ernakulam, Kerala - 683 562, India. Tel: +91 484 2867000. agappe@agappe.in

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Quality & Affordable Healthcare Solutions Worldwide... Printed and Published by Ms. Meena Thomas on behalf of Agappe Diagnostics Limited and Printed at Five Star Offset Printers, Nettoor, Cochin-40 and published from Agappe Diagnostics Limited, â&#x20AC;&#x153;Agappe Hillsâ&#x20AC;?, Pattimattom P.O, Ernakulam district, Kerala-683 562. Editor is Ms. Meena Thomas.

Sharp for accuracy and smooth in procedure open to all and no closed loops bright as future and simple as present