Results of in vitro fertilization in Italy after the introduction of a new law.

Objective: To investigate the consequences of a law introduced in Italy in 2004 that forbids the fertilization or injection of more than three oocytes for assisted reproduction and does not allow any embryo selection or cryopreservation.

Design: Retrospective observational analysis.

Setting: Subfertile patients enrolled in an assisted reproduction program.

Patient(s): Before the introduction of the law there were 1,179 cycles and after its enactment there were 1,860 cycles in 1,619 subfertile couples.

Intervention(s): Ovarian stimulation for IVF/intracytoplasmic sperm injection (ICSI) attempts.

Main Outcome Measure(s): Pregnancy and implantation rate.

Result(s): Pregnancy rates (PR) per cycle (24.34% vs. 23.11%), per retrieval (28.64% vs. 25.65%), per transfer (31.37% vs. 27.74%), and the take-home babies per started cycle (19.1% vs. 18%) was not significantly different between the two periods. After introduction of the law, the PR significantly decreased in patients whose total motile sperm count was <1 x 10(6) (40.85% vs. 23.62%) and in patients receiving two embryos (35.71% vs. 23.53%). This difference was mostly the result of a reduced PR in patients <36 years old receiving two unselected embryos (41.16% vs. 30.90%). This result was, however, obscured by the higher proportion of patients <36 years (3.9% vs. 45.12%) receiving three embryos after the enactment of the law, which lead to a significantly higher PR (28.73% vs. 37.56%) and a consequent significantly higher triplet rate (0.58% vs. 4.71%).

Conclusion(s): Women in whom elective transfer of two embryos was allowed before passing the law and couples with a severe male infertility factor had significantly reduced success rates. Although the overall PR did not change after the new law, if the transfer of frozen embryos is not considered, this was mainly the result of a higher number of embryos transferred into women <36 years old. This study shows how the negative effects of the new law are obscured by the transfer of a higher number of embryos in younger patients, resulting in a higher PR at the cost of a significantly higher triplet rate.