News Release

Italian law on ART brings problems for doctors and patients

Peer-Reviewed Publication

European Society of Human Reproduction and Embryology

Copenhagen, Denmark: Three presentations to the'21st annual conference of the European Society of Human Reproduction and Embryology highlighted the effect of the new Italian law on the choices available to infertile parents. The law came into effect in February 2004 and forbids the fertilisation of more than three oocytes at the same time, says that all embryos obtained must be transferred irrespective of their condition, and forbids embryo freezing.irrespective of their condition, and forbids embryo freezing.

The law had taken away freedom of choice on a matter that fundamentally affects personal beliefs and ethics, Dr. Monica Cattoli, from the fertility clinic Tecnobios Procreazione, Bologna, Italy, told the conference. "I think that a lay government, such as the Italian one is supposed to be, should not allow the dictatorship of the Catholic church to impose a law on all citizens."

Dr. Cattoli and her team analysed the decisions of 840 couples about their embryos which had been frozen for more than two years during the ten years preceding the new law. "We wanted to find out whether the imminent introduction of the new legislation would influence couples towards making a hurried decision on what to do with these embryos", she said.

Out of 849 couples, 66% wanted their surplus embryos disposed of ; 4.3% said they wished them to be used for research; 7.4% wanted to donate them to others; and 21.8% wished for the storage to be extended. Couples who had not had a pregnancy decided more often in favour of disposal and less often in favour of donation than others, and the request to extend storage was more uncommon among those who had already conceived spontaneously.

"Within the first two months of 2004, forty six couples gave instructions to dispose of or donate their embryos even if the two year period was not ended in order to have the right to decide themselves about the fate of their embryos", said Dr. Cattoli. "Over the entire period of our study, 77.7% of couples opted for disposal, donation, or use of embryos for research, and none of these options is available to them under the new law."

Although new embryos cannot be frozen, the law poses problems for those which were frozen before it came into force. "What will happen to these embryos?" asked Dr. Cattoli.

Commenting on the result of last week's Italian referendum, after which the law on assisted reproduction will stand because of an insufficiently high turn-out of voters, Dr. Cattoli said: "The Vatican called on Italian voters to abstain from voting so that this law would stay in place. Italy is a modern-day state and should not allow the interference of religious authorities in its affairs. In the 21st century the church should not be able to dictate Italian policy, particularly where it concerns the rights of individuals and society, and it is shocking that very few Italian politicians were prepared to stand up and say so. It is also disheartening that so many Italian people thought this was nothing to do with them, or just too difficult to understand, and therefore did not go to vote when such fundamental issues of human rights were involved."

In another presentation, Dr. Laura Rienzi, from the Reproductive Medicine department of the European Hospital, Rome, Italy, reported on her study the laboratory and clinical results obtained in the hospital before and after the application of the law. She and her team compared ICSI cycles performed in the first 4 months of application of the new legislation with those performed in the same period of the preceding year. All cycles were in women of less than 40 years. "Our results showed that the requirement to transfer all the embryos obtained, without any selection, has reduced the chances of obtaining a full term pregnancy", she said. "The cumulative ongoing pregnancy rate (which includes fresh and cryopreserved embryo transfers) was substantially higher in the pre-law period (38.7%) compared with the post-law period (30.2%). This difference was even more evident in the population of patients where more than 6 oocytes were available for the procedure (48.9% versus 26.6%)", she said.

The scientists say that they believe the difference in the success rates is due to the different quality of embryo transferred. This, together with the prohibition of embryo freezing, has meant that even in good prognosis patients, the chances of having a successful pregnancy has been substantially reduced.

Dr. Filippo Ubaldi, also from the European Hospital, Rome, told the conference that a study conducted by 7 Italian IVF Centres belonging to the Italian Society of Reproduction and analysing data from the first four months after the introduction of the new legislation had not found a statistically significant reduction in pregnancy rates per fresh embryo transfer compared to the same solar period one year before. He was sure, however, that a significant decrease would result over a longer term.

"When we compared the cumulative pregnancy rates before the law (fresh embryo transfers plus frozen embryo transfers) with those after the law (fresh embryo transfers plus the transfers of embryos obtained from frozen and thawed oocytes), we saw a statistically significant reduction of the cumulative pregnancy rates after the introduction of the new legislation", he said. "We are certain that this is related to the fact that we are no longer allowed to freeze embryos."

Many Italian fertility doctors are concerned that the legislation reduces the chances of infertile couples conceiving, he said. "Because of the reduced cumulative pregnancy rates per oocyte retrieval, the women have to undergo more procedures of ovarian super-ovulation and of ovum pick-up, thereby increasing the risks of ovarian hyper-stimulation syndrome, pelvic infections and hemorragic accidents."


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