Disorders of the reproductive system, such as male and female infertility, leiomyomata, endometriosis, polycystic ovarian syndrome, and sexual dysfunction, have a major public health and economic impact. For some conditions, such as infertility, many patients are responsible for all costs associated with therapy, and unintended consequences, such as multiple gestations, are relatively common. For other conditions, such as endometriosis or leiomyomata, definitive therapy may result in the loss of childbearing potential, and long-term evidence about alternatives is scant. Relatively few interventions for these disorders have subjected to rigorous scientific evaluation. The long-term objective of this project is to improve the care of men and women with disorders affecting the reproductive system by conducting controlled trials of selected diagnostic and therapeutic interventions.
The specific aims of the Data Coordinating Center (DCC) for the Cooperative Reproductive Medicine Network are (A) to develop trial protocols that address important clinical problems using scientifically valid, clinically feasible, and economically reasonable approaches through collaboration with participating Reproductive Medicine Units (RMUs) and NICHD staff, (B) to provide leadership in defining and measuring a range of important outcomes, including physiological measurements, clinical outcomes, and economic and quality of life measures, (C) to coordinate and/or provide all services necessary for conducting trials, including recruiting services, and quality control, and (D) to coordinate the analysis, reporting, and dissemination of trial results to the Data Safety and Monitoring Committee, the RMUs, NICHD, peer-reviewed journals, and the public.
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