`We must offer cheap treatment options'

Interview with Dr. Hugo C. Verhoeven.

"We need high-quality, minimally invasive, complete and affordable diagnosis of infertile couples," says Dr. Hugo C. Verhoeven, medical director and senior partner at the Centre for Reproductive Medicine, Endocrinology, Genetics and Anti-aging Medicine, Dusseldorf, Germany. The President and Chairman of the European Fertility Associates Board of Directors stresses the need for transparency in evaluating and treating infertility. Member of several international societies, including the American Society of Reproductive Medicine, the European Society for Human Reproduction and Embryology, and the World Endometriosis Society, Dr. Hugo argues that a regulatory mechanism is imperative in this field.

Dr. Hugo's interests extend from endocrinology and andrology to anti-aging and laparoscopy, in which areas he has given over 100 lectures all over the world and published several articles in international journals. An internationally acclaimed expert on reproductive techniques, he is an Associate Editor of the International Journal of Fertility and Women's Medicine.

In Chennai to deliver the keynote address on "The role of Endoscopic Surgery in the Management of Sub-fertility" at the third international conference on "Current Advances in Sub-Fertility and Assisted Reproductive Technology", organised by the Institute of Reproductive Medicine and Women's Health of the Madras Medical Mission, Dr. Hugo spoke to Asha Krishnakumar on the steps involved in evaluating infertility, the treatment options, the cost and ways of reducing it, and the need to develop guidelines, protocol and regulatory mechanisms. Excerpts from the interview:

As a frequent visitor to India, what do you think are the main issues underlying infertility in the country?

The problems in India are the same as in all other countries. We need high-quality, minimally invasive, complete, and at the same time affordable, evaluation or diagnosis of infertile couples.

What do you mean by high-quality diagnosis and treatment?

Everything to do with reproduction must be performed by well-trained people. There should be regular checks to ensure efficient quality management and also to find out if the pregnancy rates given by doctors are correct, whether they are doing what they say they are doing, and how.

Are you suggesting that a regulatory mechanism should be in place?

Yes. The United States and Europe have a system of accreditation and certification for quality. The idea behind that is that whatever is done is well documented and always rethought so that there is a constant effort at improving the quality of the treatment and enhancing pregnancy rates.

Also, the pregnancy rate or success rate of infertility treatments should be available to anyone. There should be audits and controls by hospitals, medical associations, professional bodies and the government.

In countries such as India where there has been a proliferation of centres offering IVF (in vitro fertilisation; in Mumbai alone there are over 20 centres), it is important to have quality control mechanisms in place. I am not talking just about high-end techniques such as PGD (pre-implantation genetic diagnosis). But the first steps in the treatment of infertility should be of high quality.

What do you mean by minimally invasive techniques in treating infertility?

It means that the patient's body should suffer the least trauma and as little pain as possible. If you put every patient through a laparoscopy, making three incisions into the abdominal wall, putting sutures, giving general anaesthesia, increasing pain and so on, then the patient will be unwilling to do it again. So we constantly try to make diagnosis as painless as possible.

For instance, in the case of IVF, the patients are very afraid of egg retrieval as a needle has to be inserted into the ovary through the vagina. To make it less unpleasant, we have to do it quickly, the needle needs to be very fine and the patient should be given the kind of sedation that will work as long as the procedure is in progress - no more, no less.

Most important is to remember that those undergoing infertility treatment are not sick and should not leave the hospital so, physically or psychologically.

Infertility treatment is expensive. How can costs be reduced so that the treatment becomes affordable to the majority of those who need it?

The cost is most important. The more you want to improve the instruments, or the more sophisticated they are, the more expensive they become. But for treatment to be more accessible, a protocol needs to be developed so that a lot of thought goes into every step of the treatment to see if it is really needed, what its cost is, what the other options are, and so on. Every woman in India has a right to become pregnant. We must offer cheap treatment options so that those who need treatment can access it.

What makes the cost of treatment so high?

Many of the examination or diagnostic steps are unnecessary and done only because they bring in money for the doctors and the hospitals. Curtailing them would reduce costs considerably.

What does reproductive medicine mean? Does it cover all artificial reproductive techniques?

Reproductive medicine is one that is used to induce pregnancies. It involves everything that has to do with reproduction. It is not just IVF, intracytoplasmic sperm injection (ICSI) or PGD. Most of our patients conceive artificially, but without using IVF or ICSI or PGD.

What parameters do we need to check during infertility treatment and how do we go about the treatment options?

For conception we need sperm cells and an egg. The two should then come together. The important questions are: can the woman produce an egg, does she have ovulation, and what is the quality of that ovulation.

That means the first step is to check the menstrual cycle of the patient - what is happening in the first part of the cycle; see the egg growing with the help of ultrasound, and ascertain the quality of the follicle (a sac containing the maturing egg) with blood samples. Both are easy and painless.

The next step is to study ovulation. Important questions are: Is ovulation really occurring? Is the follicle going back without ovulation? Is the egg coming out of the follicle? And, does it find its way to the fallopian tube?

After ovulation, the endometrium, or the inner layer of the uterus, should be prepared for implantation. Thus, the menstrual cycle observation does not end with ovulation. Most important is implantation and for that it is crucial to know what is happening between the embryo and the endometrium. This will decide whether there is an implantation or not. There are studies to show that 95 per cent of couples with normal sperms and tubes conceive but only 15 per cent deliver. This is because there are problems in implantation.

So, if we find abnormalities in any of the steps leading to implantation, we have to treat them with hormones, making sure, with the help of ultrasound, that the hormones are effective but not too effective that they will lead to high-order multiple births.

Then, if the ovulation is good, we need to decide what to do with it. There are many options: Intercourse or some kind of insemination. This leads us to part two.

We now have the eggs. We need to look at the sperm. Sperm analysis could be unpleasant for some men. But I suggest everyone to do it. Man has only a minimal contribution, but he has to lend himself to sperm analysis. He can do it (ejaculate) at home but the best place is to do it in a hospital. This step is important as the sperm is going be the gold standard in pregnancy rates as only good sperms have treatment possibilities.

Now suppose the sperm analysis is all right. Then we need to see how the egg and the sperm can come together. That means, the highway for the sperm cells from the entrance of the vagina to the end of the tube must be all right. For this, we should check the cervical canal and the mucous (that is the escalator for the sperm cells to reach the uterus). If the mucous is not okay because of some prior surgery done on the cervical canal or infections and so on, then not one sperm cell will find its way to the uterus. This is the problem in 20-25 per cent of the patients.

Thus, one can arrive at a solution in one visit. You need to check the mucous before ovulation and let the sperm penetrate in the mucous and see what happens to it under microscope. It appears simple but is a difficult technique to perform. It must be done in a laboratory and by an expert who knows exactly how to do it as too many factors can affect the results. You need to imitate what happens in the female body exactly.

Then comes the uterus. The endometrium could be abnormal because of infections such as tuberculosis or the removal of the inner layer due to abortions or interruptions. The next step is to look into the uterus - the incubator of the woman - and study the uterine cavities. Hysteroscopy and endoscopy evaluation of the uterus are important at this stage. As I said earlier, diagnosis should be minimally invasive and, hence, it is not good to use very small optics with no anaesthesia. If the doctor knows how to do it, the patient will have no pain.

Then there are problems with the tube. A woman can have no tubes, the tubes can be too short or too long, they may not be able to reach the ovary, they may be blocked, or covered with adhesions (abnormal scarring due to infections or after a surgery). Thus, there is a need to do an affordable, non-traumatic and painless evaluation of the tubes. For that we have to look through the vagina into the umbilicus (navel) with the help of a trans-vaginal endoscopy.

How do the different techniques of ART fit into the whole process of infertility treatment methods?

With all the evaluation processes complete, a summary of the patient can now be prepared. If there is problem with ovulation, hormones are given. If the sperm is not good, then we wash the sperm, take out the good sperm cells and bring them half way to the uterus or into the tubes. But if the sperm cells are not good enough, then we need to bring the sperm cells on or into the egg.

At this stage we need to think about IVF because if you want the sperm on the egg, you need the egg under your microscope. For that you have to take out with a needle the eggs from the ovaries. This has now become routine. It is done about half a million times a year. There are today over 60 million IVF babies in the world.

Depending on the quality of the sperm, you decide on the number of sperm cells (30,000-40,000 of them) to be brought onto the egg and wait for, at least, one sperm to enter the egg naturally. But if there are only four-five good sperm cells, then we need to inject one sperm cell into the egg. Then, two or three days later the embryo develops. For nearly 99 per cent of the patients, pregnancy happens at this stage. Only in the rest, do we need to test the embryos and apply the PGD technique, which may be of high quality but not minimally invasive or affordable. But till this stage, and for 99 per cent of infertile couples, we can be sure of upholding the three principles - minimally invasive, of high quality, and affordable.

What are your views on the ethics involved in using such techniques, which can easily be misused?

Each country has its own legislation, linked to religion, its past and the ethics governing its society. For example, Germany has the most restrictive law in the world. This is because anything to do with selection is completely banned because of what happened 50-60 years ago during the Second World War, when Hitler wanted to select ideal people and make copies of them. Today, in Germany, if we go to an ethics committee and say we want to select sperm cells, eggs or embryos, it would no doubt be banned immediately.

But Australia, Belgium and South Africa are liberal and will allow anything because they have no problem with their past. Even in these countries, one may need to go to an ethics committee.

The other issue in ethics is religion. For example, this can be understood by looking at the difference between the Arab, Hindu, Buddhist and Roman Catholic countries. Every religion has its input about what is or is not allowed in a country. There are countries where religion is important and there are others where religion has no influence. But most important are the views of the society in which you live, and your own. Whatever be the views of the government, ultimately the doctor becomes the upholder of ethics. Thus, every hospital should have its own guidelines reflecting the conviction of the doctors, the ethics committee, the legal system and professional bodies. It is important for every individual to have conviction on the ethical front and not to make any exceptions or compromise. While this is true of any field, it is most important in this area of medical management.