The Italian law on medically assisted reproduction: one year on

The new Italian law regulating assisted reproduction technology restricts the provision of fertility treatments to 'stable heterosexual couples' who are shown to be clinically infertile. The law, passed in 2004, states that no more than three oocytes (eggs) can be fertilised in an IVF cycle, and that all embryos obtained must be transferred simultaneously, leading to an unavoidable increased risk of multiple births. Oocyte freezing is allowed, while the freezing of embryos is banned. PGD and prenatal screening for genetic disorders have both been banned. Research using human embryos is prohibited, as are gamete donation, surrogacy and the provision of any fertility treatments for single women or same-sex couples.

There is now data confirming the predicted negative impact of the law on success rates. Seven Italian infertility centres have recently published the results of IVF cycles performed over the first four months after the new legislation came into force, in the journal Human Reproduction. Data from 1861 cycles was obtained: 900 carried out in the post-law period were compared to 961 controls performed in the same calendar period one year earlier, in the pre-law period. Pregnancy rates per oocyte retrieval in the pre- and post-law periods were 27.0 and 24.2 per cent respectively; all pregnancies obtained from frozen embryos in the first period were excluded. Obviously the prohibition of embryo freezing has markedly reduced the cumulative success rate.

Six other centres presented their data at a recent perinatal medicine conference in Cagliari, Italy. Their results show a significant decline in birth rates: at the Reproductive Biology Unit of Palermo and the SISMER Center of Bologna the likelihood of success is now almost half that obtained in the past. Pregnancy rates have, in fact, decreased from 33.4 to 18.6 per cent and from 32.4 to 18.4 per cent respectively. This fall is due to the fact that in the past, these two IVF units routinely used embryo freezing.

Three Cecos infertility centres (Rome, Florence and Bologna) have experienced a similar situation, with a marked reduction of their pregnancy rates from 37.7 to 21.5 per cent. The drop in success rate at the academic reproductive unit of Turin was less marked, falling from 35.5 to 28.8 per cent. The new rules reduce the chances of obtaining good quality embryos, and prevent the discarding of embryos with low implantation potential. The fact that all embryos must be returned to the womb explains the rise of abortion (from 17.1 to 23.1 per cent) and of twins (from 14.2 to 18.6 per cent) after IVF treatment in Italy.

Interestingly, the number of treated couples decreased from 2418 to 1746 in the same study period (March-October 2003 / March-October 2004), reflecting the fact that some patients are deciding to travel to other countries for fertility treatment. This data demonstrates another consequence of the new law, so-called 'reproductive tourism'. A survey carried out by the Forum of Genetic and Reproduction Associations in Milan, Rome and Bologna shows that almost 25 per cent of couples decide to apply to foreign private and public Centres. The researchers interviewed 324 of these couples, and asked them to complete an anonymous questionnaire about their experiences. The survey showed that Italian couples are travelling to the following countries:

Spain: 25 per cent

England: 20 per cent

Belgium: 18 per cent

Switzerland: 10 per cent

Austria: 10 per cent

Slovenia: 5 per cent

France, Ukraine, Malta and Cyprus: 12 per cent combinedFurther data was collected on the sources of information used to choose the IVF clinics abroad: communication between couples was found to be the main source, while the Internet and the press were the second and third most popular sources respectively. Another survey of 51 foreign IVF centres, carried out by Cecos, revealed that the number of Italian patients in these centres has tripled during the last year.

Italian citizens will be asked to vote on some of the controversial sections of the law on 12 June 2005. But the results of this referendum will only be valid if 50 per cent of the public vote. The Catholic Church has asked citizens not to vote, while researchers are accusing the media of not correctly informing the population of the issues. Italian IVF pioneer Carlo Flamigni, along with ten other scientists, has gone on a hunger strike to protest against the lack of accurate information on the referendum - a measure of the strength of feeling about this law.