12:26pm Sunday 31 May 2020

Italian Constitutional Court modifications of a restrictive ART law improve pregnancy rates

Dr. Paolo Levi Setti, from the Istituto Clinico Humanitas, Milan, Italy, said that this was a significant progress which would probably improve further in the future.

In May 2009, the Italian Constitutional Court outlawed most of the restrictions set by the 2004 law (40/2004), considering them to be limiting to the right of couples to have access to the best possible medical treatment, and to reduce risks and complications implicit in the application of this legislation.

In a retrospective study Dr. Levi Setti and his team, in collaboration with the Italian National Institute of Health, analysed 3,274 fresh IVF/ICSI cycles carried out in their clinic both before and after the change in the law – 2,248 before and 1,026 after. They found an improved pregnancy rate of more than 3% per started cycle in the post law-change group.

While no significant difference was found between the two groups in female age, years of infertility, and the number of oocytes retrieved, the numbers of oocytes used, embryos available for transfer and patients reaching the transfer of at least one embryo were significantly higher after the removal of the previous restrictions.

The option of freezing embryos post law-change led to a decline in the number of patients receiving no embryo at all – there were simply more embryos to chose from to ensure the best embryo was transferred. In the analysis, this led to the mean number of embryos transferred increasing significantly (from 1.82± 1.08 to 2.02 ± 1.07). Generally only two embryos were transferred to patients below 38 years of age or in patients with a good prognosis.

“Although we found no significant differences in singleton, twin and triplet pregnancies post law-change, there was a visible reduction of triplets from 2.46% to 1.68%. However, we need larger studies to confirm what we believe to be a positive change brought about by these changes in the law,” explained Dr. Levi Setti.

“A reduction in the triplet rate is encouraging, since the risks to both mother and baby associated with multiple births of this nature are high. To have more embryos available for transfer is a key factor,” concluded Dr. Levi Setti. “To achieve a higher pregnancy rate and to reduce not only triplets, but also the twinning rate, single embryo transfer can be proposed to selected couples with a good prognosis.”

These preliminary data show that it is possible to obtain the same pregnancy rates as before the introduction of the Italian law in 2004 with a significantly older population of patients. “This is an encouraging development for couples and their families,” said Dr. Luca Gianaroli, chairman of ESHRE. “We intend to continue to monitor the situation and hope to see a continuation of the trend towards more successful ART for patients in Italy.”


NB: this is the subject of a news briefing in Italian by Dr. Paolo Levi Setti at 13.00hrs (CEST) on Monday 28 June [Hall 10, Room A]

Abstract no: O-241 Wednesday 30 June 11:15 hrs CEST (Hall 10, Room B)

Italian version (pdf)


Further information:

In English and French:
Mary Rice:
Tel: +33 (0)3 21 82 54 44
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Email: [email protected]


In English:
Emma Mason
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In English, German, Spanish, French, Swedish

Hanna Hanssen
Tel: + 32 (0)2 269 09 69 (ESHRE Central Office in Brussels)
Mobile: + 32 (0) 473 35 33 81
Email: [email protected]

In Italian and English
Elisa Marcellini
Tel: +39 (0)2 76 11 51 47
Mobile: +39 340 868 96 90
Email: [email protected]


Press Office: (Sunday 27 June – Wednesday 30 June)
Mary Rice, Emma Mason, Hanna Hanssen, Elisa Marcellini

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