The effect of legislation on outcomes of assisted reproduction technology: lessons from the 2004 Italian law

Objective To evaluate the effect of the 2004 Italian regulations (insemination of ≤3 oocytes/cycle, transfer of all embryos, prohibition of embryo cryopreservation) on outcomes of assisted reproduction treatment (ART). Design Case-control study. Setting The Center of Reproductive Medicine, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy. Patient(s) Women undergoing ART for the first time. Intervention(s) Comparing outcomes of ART between 2 years before (n = 900) and after (n = 936) the law's implementation (March 10, 2004). Main Outcome Measure(s) Rates of fertilization, pregnancy, "take-home baby," and multiple pregnancies. Result(s) During the pre-law period, statistically significantly more patients reached embryo transfer (odds ratio 1.9; 95% CI, 1.5, 2.5), and embryo transfer rate per cycle was statistically significantly higher (3.1 ± 1.7 vs. 2.2 ± 0.7), but the overall transfer of good embryos was lower (OR 0.6; 95% CI, 0.5, 0.8). The pregnancy rates per aspiration cycle were similar between the periods, but the pregnancy rate per embryo transfer and birth rate with at least one liveborn baby per embryo transfer were statistically significantly lower in the pre-law period (OR 0.7; 95% CI, 0.5, 0.9). The multiple births rate was not different between the two periods. Conclusion(s) In contrast to prior pessimistic expectations, the obligation to transfer all available embryos produced from ≤3 inseminated oocytes neither reduced success rates of ART nor increased the multiple births rate.