Impact of Italian legislation regulating assisted reproduction techniques on ICSI outcomes in severe male factor infertility: a multicentric survey.

BACKGROUND In 2004, a law regulating assisted reproduction techniques (ART) was passed in Italy. The new rules allow for the formation and transfer of a maximum of three embryos at one time, whereas embryo selection and embryo storage are prohibited. The aim of this study is to evaluate the impact of these restrictions on ICSI outcome in couples affected by severe male factor infertility. METHODS Thirteen Italian ART Units were involved in this study. Data were collected on ICSI cycles performed during 2 years before (control group) and 2 years after (study group) the enforcement of the law. Only cases of obstructive azoospermia (OA), non-obstructive azoospermia (NOA) and severe oligoastenoteratozoospermia (OAT) (sperm count <or=1 x 10(6) per ml; normal forms <or=5% according to WHO) were included. Laboratory results (fertilization rate, cleavage rate and embryo quality) and clinical outcomes (clinical pregnancy rate, implantation rate, abortion rate) were compared between the two groups. RESULTS One thousand six hundred and forty ICSI cycles were examined. The control group included 843 cycles (51.4%), whereas the study group consisted in 797 cycles (48.6%). The restrictions imposed by the law significantly reduced the number of good-morphology embryos available for transfer (57.5 versus 50.1%; P < 0.001). In addition, the clinical pregnancy rate (32.6 versus 22.6%; P < 0.001) and the implantation rate (16.0 versus 12.3%; P< 0.05) per cycle were negatively affected by the enforcement of the law. In particular, dramatic reductions in the pregnancy rate (36.6 versus 15.5%; P < 0.001) and the implantation rate (17.8 versus 9.8%; P < 0.001) were observed in the NOA subgroup. CONCLUSIONS Limiting the number of treated oocytes to three per ICSI cycle significantly reduces the chance of transferring good quality embryos and thus achieving a pregnancy in cases of severe male factor infertility. NOA patients are particularly affected by this restriction imposed by the new Italian law.