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The first official data on the effects of the restrictive Italian law on assisted reproduction, approved in 2004, have been made public by health minister Livia Turco, of the centre left coalition government led by the former president of the European Union Romano Prodi.
According to Ms Turco's report to parliament, the law has resulted in a decrease in the success rate of the procedures and more multiple pregnancies and adverse outcomes.
The law was approved during the previous centre right government by a cross party majority. It prohibits the use of donated eggs and sperm; limits to three the number of embryos that can be created in each cycle; and bans embryo freezing, making it mandatory to put all fertilised eggs back into the womb. Preimplantation genetic testing is also forbidden.
Attempts to modify the law included a referendum in 2005, which did not reach the necessary quorum (BMJ 2005;330:1405 doi: 10.1136/bmj.330.7505.1405).
The report says that Italian centres that offer assisted reproduction had a 14.5% decrease in the rate of pregnancy for every 100 eggs extracted. It fell from 24.8% in 2003 to 21.2% in 2005, an absolute reduction of 3.6%. The decrease in the rate of pregnancies per embryo transfer was similar, from 27.6% in 2003 to 24.5% in 2005.
Conversely, the rate of negative outcomes, including spontaneous abortions, grew from 23.4% to 26.4%, and the number of multiple deliveries also grew, from 22.7% to 24.3%, because in 2005 more than 50% of transfers involved three embryos (because all three eggs had been effectively fertilised).
“All the figures are statistically significant,” said Giulia Scaravelli, head of the registry at the Istituto Superiore di Sanità, the national institute of health, in Rome.
But she recognised that the overall scientific value of the current report was not fully satisfactory, especially because it lacks follow-up data: “The data on procedures are gathered in aggregate form, even though the reporting system we created also allows for their collection in a disaggregated form for each cycle.”
Because the law lacks specific authorisation establishing the registry, privacy laws prevail. As a result, it is impossible to know how many Italian women repeat the treatment before obtaining a child—or before giving up—or move to a better equipped public centre in another region in addition to women who go to private centres abroad (BMJ 2006;333:1192 doi: 10.1136/bmj.39055.378356.DB).
“We are trying to overcome the current limits through a voluntary survey, starting in January 2008, in which the participant centres will collect all the data on each cycle with the couple's permission,” concluded Dr Scaravelli. “This way we also hope we'll have a much better follow-up on the outcome of the pregnancies, so that we'll also have a less approximate measure of the live birth rates.”