‘IVF law will send couples abroad’ – Josie Muscat

Childless couples: rejoice, but not too much. The goalposts of in vitro fertilisation as we know it have been changed, for now.

The doctor who for the past 22 years led Malta's most active infertility clinic is starting to think about closing shop: Dr Josie Muscat, the owner of the St James Hospital group, says he can't imagine keeping his embryologists employed now that the Nationalist government is planning to outlaw the fertilisation of more than two eggs.

Muscat, a former Nationalist MP, was emphatic in his verdict of the Embryo Protection bill unveiled this week: "They are trying to please everybody. Except patients," he said of the government's intention to effectively ban the current practice of fertilising more than two eggs and implant more than two embryos.

The government's IVF law will ban the freezing and adoption of embryos and introduce oocyte vitrification - or egg freezing - a process that, albeit experimental in some countries, is generating promising results.

Muscat acknowledges the promise of egg freezing but is careful to qualify his statement. "There are many studies, each delivering varying success rates and all of them conflicting."

But he warns that government's promise of egg freezing has yet to stand the test of success. "It worries me that we cannot fertilise more than two eggs, it's absolutely wrong. They are showing they don't understand a thing of what goes on inside the laboratory."

Muscat is naturally concerned for his own business, but also for the chances of success for infertile couples through egg freezing. MPs are about to ban the practice which he says has so far delivered an almost 60% success rate in IVF pregnancies, opting for the experimental, albeit promising, science of egg freezing.

He is even considering shutting down his operation: "Why employ an embryologist for one-off clients when people will start making use of the government service for free?" he says of his IVF operation, which on average, costs couples some €5,000 for each cycle of expensive stimulating drugs, harvesting of eggs, fertilisation, and implantation.

The draft law that will finally regulate IVF in Malta, unveiled this Friday just 24 hours after the Catholic bishops were given the heads-up to issue an ominous pastoral letter, is not without its problems. The science is promising, but as things stand, it can provide limited success to infertile couples.

In the eyes of the Nationalist government, the Embryo Protection Bill safeguards life from conception - this having been the biggest ethical dilemma both sides of the House have had to deal with since IVF regulation started being debated by MPs in 2005.

For this reason, the government is rejecting outright the freezing of embryos. With this starting-point principle, it naturally followed that they could not allow the current practice of fertilising all the eggs harvested from an infertile woman - with the result that, either all successful embryos get implanted (with concomitant health risks) or the risk that 'extra' embryos are frozen, perhaps even rejected and left there by parents who don't go for another pregnancy.

To illustrate how egg freezing became the great white hope for the Nationalists' effort to regulate IVF, it is important to briefly go through the motions of the current medical process.

When infertile women are stimulated with drugs, they produce a limited number of eggs, possibly five or six or more, but not too many: the administration of stimulation drugs must be closely monitored due to the risk of inducing fatal ovarian hyperstimulation syndrome (OHSS).

Once the eggs are harvested and fertilised with sperm, doctors hope for a good quality blastocyst after five days. Some of the embryos will simply die a natural death. The chances are that women can get one, two or perhaps three blastocysts - if they are lucky - or none at all.

Next comes implantation, and here is where it gets tricky in Malta.

"Every patient has their own particular infertility problem. You make exceptions for older women, those who have already gone through unsuccessful cycles, those with particular medical conditions: we know that just putting in two embryos, will simply not work in these cases," Muscat said.

"Infertility can be caused by multiple reasons, and just putting all women in one basket to be given just two embryos at a time, and what's more from frozen eggs, is not fair."

In the case of the St James IVF unit, which has no freezing of embryos, the successful blastocysts would all be implanted in women. But this also came at the risk of multiple pregnancies for patients who say, were blessed with three blastocysts. In the UK, the third embryo would have been frozen.

So why not freeze, I asked Muscat? Here he reveals his own ethical dilemma. "I was concerned that we could end up with supernumerary embryos left inside the freezer which parents would not claim. I didn't want to go down that road."

This was something government wanted to avoid at all costs, so fertilising all eggs at once was out of the question.

And because it wanted to avoid putting women at risk by implanting more than two embryos, the only option left was egg freezing: harvesting the eggs, fertilising two in the hope of generating one or two good quality blastocysts and implant them, while the rest of the eggs get frozen, for later fertilisation. The moral dilemma of preserving life from its conception was skirted.

But, as Dr Muscat is quick to point out, 'hope' here is the operational word.

"Although oocyte vitrification shows promise, you have to keep in mind that only a limited number of eggs can be produced by infertile women; but not all eggs that get fertilised can deliver a good blastocyst; and once they are frozen and then thawed, the success rate of their fertilisation, drops again."

Effectively, the law proposed by the government paints women into a corner. In the worst-case scenario, the first two eggs that are fertilised might not develop into an embryo and the chances of success for the frozen eggs would then drop.

The best-case scenario would be success on the first try or the successive frozen eggs, saving women the need to go through additional cycles of painful stimulation injections because they had their frozen eggs to fall back on.

Supporters promise advancement

Nottingham's Care Fertility Centre claims that in its fresh embryo transfers, 51% of women aged under 35 fell pregnant (2010 data) but that this rate dipped to 25.7% with a frozen embryo transfer: highlighting how freezing of either embryos or eggs can affect the chances of pregnancies.

In a different example - this time for women aged 40 and over - the 2012 Australian Institute of Health and Welfare report claims that the chances of achieving a live birth using a frozen egg are significantly less than from a frozen embryo - the general claim being that frozen eggs do not survive vitrification as well as frozen embryos.

But go to Rockville, Maryland where Shady Grove Fertility boasts of being the largest IVF centre in the United States with 4,489 fresh IVF cycles and 1,096 frozen embryo transfers in 2011 alone. They achieved a 62% pregnancy rate for embryo transfers for women under 35; and astoundingly 57% in frozen embryo transfers: "One of the most exciting clinical advances over the last five years has been in the area of egg and embryo vitrification," the clinic claims - which is why the key to success is the betterment of the science.

The international journal Nature says the growth of egg freezing is blurring the 'experimental' label it has so far earned, but success rates are not easily available - not even with a cursory internet search. And this lack of transparency contrasts sharply with that for IVF, for which the results of all cycles are reported to the responsible medical authorities of countries.

Without putting too fine a point on it, not even the Maltese health minister had success rates of oocyte vitrification at hand when unveiling the Embryo Protection bill this week.

Nature says advances during the past few years have significantly increased success rates, and now as many as 50-90% of eggs can survive slow-freezing and thawing. Worldwide, it is estimated that fewer than 2,000 people have been born from frozen eggs, about 400 of them in the United States.

A substantial number have been born in Italy, where the freezing of embryos was not permitted until recently, but egg freezing was allowed.

Only four babies had been born from frozen eggs by the end of March 2009 in the United Kingdom, according to the latest figures from the Human Fertilisation and Embryology Authority.

Josie Muscat, on his part, sounds a warning: "We are going to open our patients to some IVF tourism... abroad. More people are going to leave Malta to get IVF treatment abroad because they will look for better results abroad, where they will transfer more than two embryos if necessary - or get better success rates from frozen embryo transfers."