In-vitro fertilisation experts are at odds on whether the law should be changed after it emerged the treatment’s pregnancy rate has almost halved.

The figures released for the first time by the Embryo Protection Authority showed that 28 per cent of IVF treatments in 2013 resulted in pregnancy, down from the 50 per cent claimed by the only private operator in 2012.

Paul Sultana, laboratory director at the private St James Hospital that pioneered IVF in Malta 20 years ago, criticised the legal restriction that prevented doctors from fertilising more than two eggs.

“This bogus law is compromising the success of the process and it has evidently halved the chances of achieving pregnancy,” he said.

Dr Sultana said this was unfair on patients who endured the trauma and expense of IVF treatment.

He acknowledged that the reason for the two-egg fertilisation limit was to avoid creating multiple embryos that would have to be implanted in the woman’s womb, increasing the risk of multiple pregnancies and potential health problems with the newborns.

We are the only country in the world that has an IVF programme that does not allow embryo freezing

“I can understand this concern but to avoid this predicament without compromising pregnancy rates, the only option is to freeze embryos. We are the only country in the world that has an IVF programme that does not allow embryo freezing.”

Such freezing is only legally permitted when fertilised eggs cannot be transferred to the woman, such as if she suffered an accident before implantation.

However, the law allows eggs and sperm to be frozen.

Expert opinion is split over whether the less ethically contentious frozen eggs give better results than frozen embryos.

Dr Sultana called for the law to be revised as had been promised when it was enacted in 2012 – but family doctor Michael Axiak disagrees.

The former chairman of the bioethics committee, a government advisory board, said he “expected” the pregnancy rate to go down but cautioned against a direct comparison with the situation before the law came into force.

“We had situations before 2013 when three or sometimes even more embryos were implanted that obviously increased the chances of pregnancy but also the risk of multiple births,” he said.

Dr Axiak noted that the bioethics committee originally recommended a limit of three embryos to be implanted but paediatricians were concerned about the high rate of multiple pregnancies.

“The two-egg limit was a compromise that we had to achieve between having a high pregnancy rate and reducing the number of multiple pregnancies that increased the risk of neonatal mortality,” he said.

Dr Axiak shunned the argument that a balance could be found by allowing doctors to fertilise more than two eggs –increasing the chance of obtaining viable embryos – and freezing the extra embryos.

He said the principle issue was the number of embryos that should be transferred to a woman’s womb, insisting there was little difference between success rates of using frozen eggs and frozen embryos.

“I do not believe the State should go down the road of allowing embryo freezing because this will lead to human life being discarded,” Dr Axiak said.

It seems there is no intention to change the rules.

Health Parliamentary Secretary Chris Fearne avoided a direct question as to whether the government will revise the two-egg limit but insisted that the pregnancy rates quoted by private clinics were issued before the practice was regulated by law.

“When present rates are compared with those of other countries, where regulations and legislations have been enacted, the statistics quoted in the report of the Embryo Protection Authority are in line with international success rates,” Mr Fearne said.

He noted that the latest figures presented in 2013 by the European Society of Human Reproduction and Embryology showed that success rates in Europe from “a single fresh” treatment cycle of IVF have stabilised at around 32 per cent of pregnancies.

The compromise achieved when the law was being drafted came after interminable hearings by a parliamentary committee headed by then Nationalist MP Jean Pierre Farrugia that was tasked to address embryo freezing.

Experts had warned the pregnancy rate would drop if a two-egg limit was imposed without allowing embryos to be frozen.

Social Solidarity Minister Michael Farrugia, speaking in his personal capacity as a member of that committee, believes the situation should be given more time before changes to the law are contemplated.

There are many “negative variables” at stake such as the age of women undergoing IVF and the number of past failures that had to be taken into consideration, he added.

“I would at least give the law another year for a qualitative analysis of the figures at hand after which it could be re-evaluated,” he said.

Dr Farrugia also noted that before the IVF law no official statistics were collected and no monitoring of services at the only private IVF clinic was ever done.

“It could be that the practices adopted then were not necessarily in line with the best practice model in force today [of implanting only a maximum of two embryos],” he said.

The debate: fertilising two or more eggs

The law allows doctors to try to fertilise only a maximum of two eggs, which means they could end up with zero, one or two embryos.

If doctors are allowed to fertilise more than two eggs the chances of ending up with viable embryos are heightened.

Transferring embryos to the womb after their initial cultivation in a petri dish will not necessarily result in pregnancy.

Transferring more than two embryos automatically increases the chances that one or more embryos develop into a pregnancy. However, the transfer limit of two embryos was intended to cut down on higher-risk multiple pregnancies.

If lawmakers change the law to allow the fertilisation of more than two eggs but retain the limit of two embryos that can be transferred to the woman they will be left with the question of what happens to the extra embryos.

IVF practitioners have argued in favour of allowing those extra embryos to be frozen for future use by the woman.

The flipside to this argument has ethical considerations at heart. Some argue embryos deserve to be treated with the utmost dignity since they also have a right to life, which would be compromised by freezing.

The law allows eggs to be frozen. Although this is not ethically contentious, practitioners argue it diminishes the chances of obtaining viable embryos on the first attempt.

They also say frozen embryos have a higher chance of leading to pregnancy than frozen eggs.

Some experts dispute this line of thought and insist there is little statistical difference between the success rate of frozen embryos over eggs.

ksansone@timesofmalta.com