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Maze of the IVF law - Josie Muscat

Embryologist adding sperm to egg in laboratory of reproductive clinic. ‘Claims of discrimination between embryos are fallacious, for a defective embryo will not implant.’

Embryologist adding sperm to egg in laboratory of reproductive clinic. ‘Claims of discrimination between embryos are fallacious, for a defective embryo will not implant.’

My decision to join the IVF debate was taken after President Marie- Louise Coleiro Preca called for a non-partisan and informed debate.

I state my interests at the outset. I introduced IVF in Malta 27 years ago, gave birth to the first IVF baby, the first ICSI (intracytoplasmic sperm injection) baby and the first baby by PESA/TESA techniques (used to help men who are not producing sperm).

Since then, Saint James Infertility Clinic (wholly private) has helped hundreds of women to become pregnant. Hundreds of singletons, quite a few twins, very few triplets and one quads. I work only in the private sector where no help whatsoever is provided to my patients who, as taxpaying citizens, give as much support to Malta’s health services with their NI and VAT as those availing themselves of a government service introduced four years ago – so much for equality.

In spite of incessant propaganda which gives the impression that the government started it all, at Saint James we still kept going albeit with slightly reduced numbers (patients from Libya have not been given visa permission to have IVF in Malta for the last four years). This hit our numbers hard.

I am also a practising Roman Catholic. I introduced IVF in Malta precisely to help those couples who were finding it difficult to have children. At that time no rules or laws existed. I could have gone the whole way with embryo freezing and Parliament would have faced a fait accompli. In the absence of legislation, we set our own rules and decided not to go for embryo freezing for the same reasons and dilemmas that we face today. What would we do with the excess, unclaimed, frozen embryos?

I will not go into the scientific debate of when life begins. Others have done that better then I can. But since we started IVF/ICSI procedures, great strides forward have been made in the fertility sector, pushing success rates upwards.

Until the present (in my opinion unpractical and unfair) Embryo Protection Act was introduced, our success rate of 60 per cent was comparable to that of clinics abroad and this without embryo freezing, CCS (comprehensive chromosome screening) or PGD and PGS (preimplantation genetic diagnosis and screening). Our policy was to fertilise four follicles and implant all embryos that resulted. We had a few triplet pregnancies and while some miscarried (singletons and twins miscarried too), only once in 26 years did we have quads.

As our methods improved so did our success rates. But we kept the same policy. On one occasion we had four sets of triplets and lo and behold all were premature at the same time, causing havoc in the ICCU.

This was the spark that initiated the IVF debate that led to the enactment of the Embryo Protection Act. This law is mainly concerned with the embryo, giving no importance to the protagonists that IVF is meant to help (the prospective parents) while treating doctors as criminals, facing them with the possibility of heavy fines and imprisonment. No other such law exists for other specialists and subspecialties.

Despite all this, our success rate still hit the 50 per cent mark on average. On three successive occasions it plunged (for reasons we have now corrected) but we have once again hit the 50 per cent, albeit our numbers are smaller. Twenty-six years ago, success with frozen eggs was almost nil but recent discoveries have improved this to 30 per cent or so abroad – locally it is in the 22 per cent region.

It has been claimed that the amendments to the present law will improve the success rate and the birth rate. I beg to differ.

This is a complex subject that cannot be dealt with seriously in one article or a one-hour TV debate. Every couple/person is a different story. In one session one could see as many as 20 women with an equal number of diverse problems, all having different treatments and outcomes. This is the reason for the low success rate. People coming for IVF will have gone through different kinds of treatment unsuccessfully. IVF would be their last resort.

The dangers of having children late

A serious contributing factor to the low success rates is that women are postponing childbirth. As age progresses (especially after 35) the number of reserve eggs falls rapidly and the quality (DNA) deteriorates. After 40, 74 per cent of a woman’s follicles are defective and so are men’s sperm once they reach 50.

It has been claimed that the amendments to the present law will improve the success rate and the birth rate. I beg to differ

Today we know for certain that the reason why some 80 per cent of cases fail is due to a defective embryo resulting from a defective sperm or ova. The lining of the uterus, which is very selective, fails to talk to a defective embryo. If it fails to detect and eliminate a defective embryo, the mother would test positive, give the news to the would-be grandparents and friends, and rejoice with her partner. At six weeks gestation she may see the embryo on ultrasound and clearly hear the embryonic heart beating, only to be told that all is lost when she calls in her ninth or tenth week of pregnancy, with despair taking over from rejoicing.

So we are left with a baby with one of many possible forms of disability, although some of them die in the uterus or after birth. This is the reason why so few babies are born with a disability (not counting those that suffer a mishap during birth).

Embryos for sale?

So what, from that which is available today, will truly increase success rates in IVF? Two main steps need to be taken: pragmatic diagnosis and comprehensive chromosomal tests and embryoscopies. These will not be allowed under the proposed amendments. This is why I totally disagree that this law will increase the success rate or increase the number of births.

To increase the number of births we have to think of new ways of enticing women to have more children, and if we want to help people facing infertility problems, we have to find a way to solve the excess embryos problem.

This law does not eliminate such problems. On the contrary, for various reasons, in a few years’ time we will be faced with a huge number of supernumerary embryos and we will have to decide whether to discard them or use them for research purposes.

I will not discuss same-sex or single-parent pregnancies. I just thank God that I will not be around in 30 years’ time to see the fate of our yet to-be-born babies with unknown fathers or mothers and all the problems our actions of today will create for tomorrow. I will certainly not want to be an MP who with my vote will have contributed to the hardships and problems such children and our small country will have to face 30 years hence.

Despite all the articles and debates we have had, so far no one has come out with practical suggestions on how to improve the proposed law.

Wandering in the maze

I will attempt to set the ball rolling in the hope that some acceptable solutions may be found. There will still be the special cases that require individual solutions. One-size medicine does not work very well and is unfair and impractical. General principles can only “get us in the game”. Age and the number of reserve eggs are very important factors (assuming that hormones and other factors are in the normal range) in predicting success rates.

I would propose that for women up to the age of 35, not more than two eggs are fertilised, as is the position today. The chances of these not fertilising are low, chances of pregnancy are high (60 per cent or more) and the chances of twins gestation is also high. Even outcomes with frozen eggs are good at this age. Should there be problems with AMH (reserve eggs), hormones, endometriosis, etc, then each woman’s problems should be dealt with accordingly. How one manages an individual patient is where the art of medicine comes into play.

I cannot understand how members of the Embryo Protection Authority and their non-medical experts can decide a woman’s fate when her treating specialist has not been given a chance to explain or debate her particular case.

For women between 36 and 39, I propose that four oocytes (eggs) are fertilised whatever the outcome and the number of tries. All embryos will be transferred. The chances of having three embryos is very slim since many oocytes are DNA damaged and chances of triplets are even slimmer since at this age many factors come into play. Should the prospective parents have a high AMH, these should be treated as a case below 36 years.

For women of 40 and older, I would go to four or five embryos depending on the level of AMH. In the case of more than three embryos fertilising, I would recommend freezing excess embryos. These can always be made use of if the woman does not get pregnant or can be eventually donated, but the number will be small and manageable.

For women over 42, the present law MUST be amended. The blanket refusal by the authority to allow a couple to have an IVF because of their age, when their hormone levels are still showing that they have a good chance of pregnancy, is unfair, unjust and discriminatory.

How does the authority justify its decision to refuse IVF to all women over 42 when women not requiring IVF can have and do have children albeit in small numbers? The same reasoning goes for women under 25. Is this not blatant discrimination? This when teenage pregnancies are at record numbers with the State providing all imaginable social services.

If a woman’s AMH is still within the range of fertility then there is no reason she should not be allowed to try to have her own children given that most of the reasons for infertility stem from the male side. If the government wants to limit the age for IVF treatment due to difficulties at Mater Dei, then at least it should allow such people to have an IVF elsewhere in our country.

The above will not push up the success rates by heaps and bounds but it is more justifiable and less discriminatory than the present law. I still believe that PGD/CCT should be allowed.

I thank God I will not be around in 30 years’ time to see the fate of our yet to-be-born babies with unknown fathers or mothers

 The claims that this will result in discrimination between embryos is fallacious, for a defective embryo will not implant. Nature itself rejects it. What we are doing today is transferring defective embryos certainly destined to be rejected, resulting in physical, mental and financial traumas for the couple which are totally unnecessary.

Storage abroad?

PGD/CCT should be allowed after two failed tries and the same criteria as above could be adopted. In cases where more than 50 per cent of embryos produced are defective, then each case should be discussed with the authority and a fair solution found, ever with the aim of helping the mother to conceive while at the same time keeping the number of supernumerary embryos as low as possible.

Let’s keep in mind one important fact – to help women conceive while at the same time have the lowest possible supernumerary frozen embryos will not change anything. Not, that is, unless we find a workable, sensible solution. For what is happening today will keep on happening and a huge number of Maltese frozen embryos will be stored abroad, destined for destruction or experimentation.

A final observation. We need not mimic all that happens abroad. We must tailor our solutions to our own needs. Laws regulating infertility differ in all countries and are the reason for infertility tourism. There is no ideal law. It all depends on what we want to achieve and how far we want to go. Every country decides its own laws. I totally disagree with a free-for-all attitude in the name of progress as this will lead to abuse and suffering for all concerned.

Moreover, France, Germany, Italy, Spain, Portugal and Bulgaria prohibit all forms of surrogacy. Are these retrograde counties?

Finally, please take into consideration the size of our island compared with other countries we are trying to mimic.

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