The science of ART

Assisted reproductive technology has brought hope to numerous infertile couples in India and many other countries.

TAPPING his feet on the granite-tiled fifth floor corridor of the Institute of Reproductive Medicine and Women's Health in Chennai's Madras Medical Mission (MMM), Mohan sits nervously at the edge of a moulded chair. His wife Shanta, sitting next to him, appears more composed but her constant fidgeting with her handbag gives her away. This middle-aged couple is nervous because in a few minutes the Institute's Medical Director, Dr. Thankam R. Varma, is to evaluate their chances of having a baby.

At least 25 childless couples queue up every day to meet Dr. Thankam Varma, former Medical Director of Infertility Services at St. Georges Hospital and Medical School, London, who built from scratch the sub-fertility department at the London hospital and worked there for 26 years. Most patients at the Institute are in their late thirties to early forties, having spent several years hoping against hope, and experimenting with superstition and pseudo-science, before deciding to resort to assisted reproductive technology or ART, a set of treatment options for infertile couples (a couple is considered infertile if the woman does not conceive after 12 months of unprotected intercourse). The couples are deterred neither by the high cost of the treatment - it starts from Rs. 70,000 - nor by its low success rate of 30 per cent. The social stigma, and even ostracism in some cases, make them clutch at any straw, regardless of cost or other considerations. Dr. Varma says: "The agony of childlessness is impossible to describe or even understand."

Unlike any other medical problem, the social connotations and repercussions of infertility are severe, especially for the woman. A woman who is unable to bear a child, whether it is because of her problem or her husband's (nearly 70 per cent of infertility in India is because of the male factor), is treated badly. Often, she pays a heavy price - she is thrown out of the house or her husband remarries. Some women even commit suicide.

In India, one in five couples is childless. Twenty per cent of the women who get married, get pregnant in the first month and another 40 by the end of six months. Of the remaining 40 per cent, 25 per cent get pregnant in two years' time while 15 per cent remain childless and needing help. Of those needing help, 25-30 per cent will require ART to conceive while the rest can be treated using simple interventions. Of those undergoing ART, one in three gets pregnant the first time. According to Dr. Varma, age, particularly of the woman, is crucial. A woman over 35 years, though she can be made to produce an egg, may not yield one of good quality.

One of the popular ART procedures is in vitro fertilisation or IVF, which involves stimulating the ovaries for multiple egg production, egg retrieval, fertilisation, embryo culture and embryo transfer. It has, in the 25 years since its first successful trial, become a routine procedure today. Over half a million babies are born with the help of the IVF technique every year.

Dramatic advances have been made in ART in the last decade. Thanks to technology, ART has come a long way from simple ovulation induction to intracytoplasmic sperm injection (ICSI), embryo transfer, assisted hatching, percutaneous epidydimal sperm aspiration (PESA), testicular sperm extraction (TESA), cryopreservation, pre-implantation genetic diagnosis (PGD) and egg donation.

According to Dr. Lucas Gianaroli, Scientific Director, Italian Society for Studies in Medical Reproduction, Bologna, Italy, PGD is one of the most recent techniques used in ART. It provides an alternative to more traditional forms of prenatal diagnosis. For long infertility was thought to be caused by some mechanical or endocrinological problems - such as problems in the abdomen owing to a previous surgery, inflammatory diseases, limited sperm count in males and so on. Later it was found that genetics, rather than standard theories, explained infertility in some couples; nearly 10 per cent of infertile couples had genetic problems.

PGD enables physicians to identify genetic diseases in the embryo prior to its implantation in the mother's womb. The abnormal embryos are removed. This is of particular help to couples with such genetic disorders as cystofibrosis, Huntington's disease, muscular dystrophy, thalassemia and some types of cancer, and at risk of transmitting them to the offspring. This method is also used for human leukocyte antigens (HLA) matching. There are 200,000 HLA systems that make transplant compatible. A couple with a child who has medical problems such as thalassemia or a certain type of anaemia and needs a compatible donor can even opt to "design" the embryo in such a way that it can be used as a donor for the existing child. This, of course, raises a number of ethical issues. While IVF and ICSI have brought to the world over 60 million babies, PGD, being a relatively new technique and also very expensive, has had only 1,000 success stories.

Today, couples can make use of methods of storing sperms and ovarian tissues if they need to postpone having a child. This is particularly useful if one of the spouses is being treated for some disease, such as cancer, that would depress the sperm count and, hence, lower the chances of normal conception. Storing eggs is difficult as they are more delicate and cannot withstand the pressures of freezing and thawing. Embryos and sperms are tougher and can be stored for long periods - even up to 100 years. But this again raises certain questions, especially ethical.

All problems relating to infertility, including examination, need to involve both husband and wife. According to Dr. Thankam Varma, this is vital because in 70 per cent of infertility cases in India, the problem lies with the man. The main problems in men patients relate to the quantity and quality of sperms produced. This may be because of the quality of life, the stress levels, the use of tobacco or poor-quality alcohol or drugs (the sperm quality and quantity drops to rock-bottom levels if a person uses drugs) and pollution. Sometimes, drugs given to treat some other disease may depress the sperm count.

Says Dr. Thankam Varma: "We greatly underestimate the impact of stress in India. The stress levels of women in India are at least three times higher than that of their Western counterparts."

The most important aspect that should be taken care of while dealing with infertility in India is educating the doctors as well as the couples and their immediate family members. Doctors first need to know the main causes for infertility in women - infections, fibroids, endometriosis, termination of pregnancy, sexually transmitted diseases and so on. In India, infection - when the fallopian tube gets blocked - is the main cause for female infertility. As women in India reach menopause much earlier than women in the West, there is little time for detailed investigations. The investigations now are at best unstructured and haphazard. Says Dr. Thankam Varma: "We need to act quickly and for that we need guidelines."

BUT there is no structured training, protocol, guidelines or a regulatory body to oversee infertility treatment in India. According to Dr. Thankam Varma, everyone seems to offer infertility or sub-fertility treatment as it is a lucrative business. There are over 30,000 infertility clinics in the country, 17 in Chennai alone. There have been advertisements in newspapers offering treatment for as low as Rs.1,000. According to Dr. Thankam Varma, there is not even one in a million chance that the patient will conceive in such cases. Agrees Dr. Kamala Selvaraj, Associate Director of the Chennai-based GG Hospital and head of the hospital's Fertility Research Centre: "Fertility clinics have mushroomed in Chennai, claiming incredulous success rates that are not at all possible."

The crucial factor in ART is the cost. IVF costs Rs. 70,000-80,000 for a 15-day treatment cycle. Further, micro-manipulation such as injecting sperms into the egg (as in ICSI), costs another Rs.30,000; assisted hatching costs another Rs.30,000. Implantation and genetic diagnosis will require a few thousand rupees more. Yet, infertility is neither allocated a share in the healthcare budget, nor is it covered by insurance. This is because it is generally thought of as "a luxury", a "social" rather than a "medical" need. Many people even question if it is a disease at all. But, in fact, most cases of infertility are caused by diseases, negligence and accidents. Infertility causes enormous psychological pressure on the patient, which can be compared to that experienced by patients of cancer or heart diseases. Says Dr. Hugo C. Verhoeven, Medical Director and Senior Partner, Centre for Reproductive Medicine, Genetics and Anti-Ageing Medicine, Dusseldorf, Germany: "It is certainly not right to call infertility treatment as lifestyle choice."

Medical professionals running ART programmes need to be very careful and above board as there is room for both manipulation and mistakes. According to Dr. Hugo, no other medical area raises as many social and ethical issues as infertility.

Should infertility be treated as a medical or a social problem? Even while researchers, social activists and doctors heatedly argue this point, there are many others who contend that ART is unnecessary. A common contention is that a highly populated country like India, which is unable to provide basic healthcare for all, has no business investing resources in an expensive technology that benefits only a few. But researchers, who agree that there is a lot more excitement and prestige working in this area, insist that these technologies have been developed in response to a genuine demand.

The use of ART has raised many ethical issues around the world. The case of a 37-year-old Afro-American woman who opted to be implanted with the ovum of a white woman (ostensibly because a white child has access to a higher quality of life), has embroiled Britain in a heated debate. In another instance, British doctors have refused to allow a Pakistani couple to have a blond-haired, blue-eyed baby boy. But designer, made-to-order babies can be a reality. There have also been instances of couples wanting to have just foetuses with particular genetic traits in order to retrieve organs to help an ailing older child. This has raised a number of ethical and moral questions.

In India, it is a well-known fact that there is a strong preference for sons and fair babies. Asks Dr. Meera Kosambi, Director, Research Centre for Women's Studies of SNDT Women's University, Mumbai: "What is there to prevent this technology from being misused, just as amniocentesis has been?"

The Catholic Church has been among the most vociferous critics of ART. The Church not only condemns birth of babies achieved through the donations of sperm or ovum, but also prohibits the extracorporal union of the husband's sperm with the wife's ovum. "From the moral point of view, procreation is deprived of its proper perfection when it is not desired as the fruit of the conjugal act," says aVatican document.

But what of the feelings of deprivation and social ostracism that traumatise childless couples? The Catholic Church recommends adoption. Proponents of this view say that "there are more children waiting for mothers than there are wombs waiting to be filled."

Dr. Thankam Varma reacts strongly to this: "Adoption is not the sole responsibility of the 20 per cent of the couples who are infertile. Why should the 80 per cent keep producing and leave those who cannot conceive to adopt?" Though researchers are aware that technology has not advanced sufficiently to go in for a mass artificial procreation programme, they are aware of the need for regulation to protect against the indiscriminate use of ART.

Until the guidelines are formulated, scientists hope that the traditional values that govern society will prevent the misuse of ART. Says Dr. Lucas Gianaroli: "Techniques are harmless, but society's moral and ethical values are complex. Science, which is value-neutral, gives us technology, the adoption of which depends on individual societies."