Five years (2004-2009) of a restrictive law-regulating ART in Italy significantly reduced delivery rate: analysis of 10 706 cycles

Study question: Law 40/2004 enacted by the Italian Parliament established a long list of restrictions for ART procedures. We investigated the differences in the delivery rate of all ART cycles performed before and after the introduction of the law. Summary answer: This large and extensive comparative analysis of ART outcomes prior and after the introduction of the Law 40 revealed a significant reduction in pregnancy and delivery rates per cycle, independent of age or other clinical variables, once the law went into effect. What is known and what this paper adds: Several studies have been published on the effect of Law 40/2004 on ART outcomes, some authors demonstrating a negative impact of the law also in relation to specific aetiologies of infertility, other authors showing opposite conclusions. Our study, the first based on the analysis of a so large number of cycles, clearly demonstrated a negative effect of Law 40 restrictions on ART procedures, as an independent factor responsible for the reduced delivery rate of IVF cycles. Design: Retrospective clinical study Partecipants and setting: 10,706 cycles were analysed, 3,808 performed before and 6,898 cycles after the application of the Law. An intention to treat statistical analysis was performed to detect pregnancy and delivery rates (pregnancies ≥ 24 weeks) per started cycle. A p value <0.05 was considered statistically significant. We analysed different outcomes: differences in fertilization, pregnancy, and delivery rate, multiple pregnancies and miscarriage rates between the two time periods. Main results and the role of chance: The delivery rate for started cycle was 20% before and 16.0% after the introduction of the Law representing a 25% reduction (p<0.001). The multivariate analysis, corrected by age, basal FSH level, number of retrieved oocytes and total progressive motile count, showed a 16% lower delivery rate (OR 0.84 CI 0.75-0.94) and confirmed the effect of the Law as an independent factor responsible for the reduced chances of a successful outcome.