STUDY QUESTION<\/p>\n
Was the delivery rate of ART cycles negatively affected by the enactment of the Law 40\/2004 by the Italian Parliament which imposed a long list of restrictions for ART procedures?<\/p>\n
SUMMARY ANSWER<\/p>\n
This large and extensive comparative analysis of ART outcomes prior to 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.<\/p>\n
WHAT IS KNOWN ALREADY<\/p>\n
Several studies have been published on the effect of Law 40\/2004 on ART outcomes, some authors demonstrating a negative impact of the Law in relation to specific etiologies of infertility, other authors showing opposite conclusions.<\/p>\n
STUDY DESIGN, SIZE, DURATION<\/p>\n
Retrospective clinical study of 3808 patients treated prior to the enactment of the Law, September 1996–March 2004 (Group I) and 6898 treated during the Law, March 2004–May 2009 (Group II).<\/p>\n
PARTICIPANTS\/MATERIALS, SETTING, METHODS<\/p>\n
A total of 10 706 ART cycles were analysed, 3808 performed before and 6898 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<\/I> value of <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.<\/p>\n
MAIN RESULTS AND THE ROLE OF CHANCE<\/p>\n
The delivery rate for started cycle was 20% before and 16.0% after the introduction of the Law representing a 25% reduction (P<\/I> < 0.001). The multivariate analysis, corrected by female age of >38 years, duration of infertility, basal FSH level and number of retrieved oocytes, showed a 16% lower delivery rate (odds ratio: 0.84; confidence interval: 0.75–0.94). This statistical approach removed the risk that the observed effects were due to chance and confirmed unequivocally that the Law was an independent factor responsible for the reduced likelihood of a successful outcome.<\/p>\n
LIMITATIONS, REASONS FOR CAUTION<\/p>\n
This is a retrospective study. A prospective randomized study, with patients treated in the same time period and randomized to restrictions or not, would have minimized potential limitations due to differences in years of treatments.<\/p>\n
WIDER IMPLICATIONS OF THE FINDINGS<\/p>\n
Our findings based on the analysis of such a large number of cycles proved clearly and unequivocally that imposing restrictions on the practice of ART penalized patients. These data represent a relevant clinical contribution for countries still debating the enactment of restrictive limitations of ART.<\/p>\n
STUDY FUNDING\/COMPETING INTEREST<\/p>\n
This investigation has been supported by a finalized grant from Lombardy County, Italy (DGR 7255, 3 July 2008).<\/p>\n
Source: STUDY QUESTION Was the delivery rate of ART cycles negatively affected by the enactment of the Law 40\/2004 by the Italian Parliament which imposed a long list of restrictions for ART procedures? SUMMARY ANSWER This large and extensive comparative analysis … Continue reading
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