A draft law regulating IVF treatment locally has kicked up a storm among Malta’s medical community, with opinion split as to whether the fertilisation method to be used will actually work.
The law, which is open for public consultation until September 14, will require all clinics offering IVF to only successfully fertilise a maximum of two eggs per woman at any one time.
Excess eggs will be snap-frozen in vats of liquid nitrogen, allowing doctors to extract, thaw and inject them with sperm one-by-one until they end up with the two fertilised eggs allowed by law.
The snap-freezing process, known as oocyte vitrification, is a relatively new one and has only come into mainstream medical use over the past few years.
And while the government is convinced the procedure will successfully bypass the ethical minefield of embryo freezing, a leading figure in local assisted reproductive technology remains unconvinced.
“All this Bill does is give parents false hope. The technology they’re proposing is only a couple of years old. There are very few pregnancies from eggs which were frozen – you might get embryos, but translating those into pregnancies is a different story,” said Saint James Hospital’s medical laboratory director, Paul Sultana.
Saint James Hospital has been offering IVF privately for a number of years. In the absence of regulation, the hospital implants any successfully fertilised eggs into a woman, to avoid having to destroy or freeze embryos.
The hospital will now have to obtain a licence to continue to offer IVF locally – and doing so will mean having to conduct the procedure using oocyte vitrification.
But Mr Sultana was livid at the government’s decision to adopt the “very experimental” technology which, he said, was still in its infancy.
“I observed a clinical trial of the technology in Germany. And from the 15 women taking part, not a single one got pregnant. Malta has no real experience of IVF, and suddenly we’re meant to successfully implement this experimental technology.”
Mr Sultana’s scepticism was counterbalanced by Pierre Schembri Wismayer, who heads the Anatomy department within the University of Malta’s medical faculty.
“Oocyte vitrification is relatively new, but it is proven and the medical literature supporting it is out there for all to see. Success rates are comparable to other IVF methods and more and more clinics are making use of it,” Prof. Schembri Wismayer said.
“Nine-hundred babies have already been born across the world thanks to oocyte vitrification, which is significant considering the process is still relatively new.”
The two sharply opposing perspectives were balanced out by gynaecologist Donald Felice, who said the process had “enormous potential” but was still in the process of becoming established.
“Its popularity is increasing, but the fact that it’s such a new process means that statistics about the procedure are still thin on the ground,” Dr Felice noted.
Articles about oocyte vitrification published in recent months seem to back up Dr Felice’s caution. A study by the GENERA Centre for Reproductive Medicine in Rome, Italy described vitrification as “efficient and reliable” – a finding supported by the Instituto Valenciano de Infertilidad in Valencia, Spain, which, however, added the caveat “more large controlled clinical trials are needed”.
Researchers at the Royal Women’s hospital in Melbourne, Australia, urged caution. “There are key limitations associated with the available evidence base, including a paucity of randomised controlled trials [and] limited reporting of live birth outcomes,” researchers noted.
The former chairman of the Bioethics Consultative Committee, Maurice Cauchi, said all members of the public could benefit from this long-overdue Bill. The problem with the Bill, he said, was to try to find a reasonable compromise.
“Too many eggs and you end up with multiple pregnancy – considered a medical disaster – too few and the chances of a successful pregnancy are considerably reduced.”
Asked if it was correct to limit IVF to heterosexual couples who are either married or in a stable relationship, Prof. Cauchi said the majority in Malta would probably agree with this proposal.
“In places like Australia, third party donation of sperm or eggs has become standard practice. I do not think Malta is ready for this yet.”
Meanwhile, Health Minister Joe Cassar and Justice Minister Chris Said jointly visited Mater Dei Hospital’s IVF clinic yesterday. Set up in 2004, the clinic has sat unused ever since.
As the ministers were shown around the clinic, Dr Cassar noted that much of the equipment had never been commissioned and was therefore still under guarantee.
He also opened the door to further public-private partnerships, saying private clinics offering IVF could, against payment, decide to start storing frozen eggs at the MDH egg bank.