The 2004 Italian legislation on the application of assisted reproductive technology: epilogue

To evaluate how the unique Italian fertility regulations (≤3 inseminated oocytes/cycle, transfer of all embryos, prohibition of embryo cryopreservation) affected outcomes of ART.

Case-control study from the Center of Reproductive Medicine, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy. We compared outcomes of ART patients between five years before (n=1791) and five years after (n=2474) the implementation of the law.

The mean embryo transfer (ET) rate was 3.1±2.1 and 1.7±1.1 before and after the law. Significantly more ICSI procedures were performed in women above 35 years old during the post-law period. The ET rate was higher before (88.6%) than after (80.5%) the law (OR 1.9, 95% CI 1.6, 2.2) especially in women >37 years undergoing ICSI (88.2 vs. 76.1%; OR 2.3, 95% CI 1.3, 4.2). The clinical pregnancy rates were practically unchanged but the proportion of triplet births significantly decreased after the law (10.3 vs. 4.1%, OR 2.7, 95% CI 1.4, 5.0).

In contrast to interim analyses, we found that the statutory obligation to transfer all available embryos produced from up to three inseminated oocytes reduced the ET rates, especially in older women, and decreased the triplet births rate.