DATA COORDINATING CENTER REPRODUCTIVE MEDICINE NETWORK

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The cooperative Reproductive Medicine Network is designed to carry out large, multicenter clinical trials in the areas of male and female infertility and reproductive diseases and disorders. By testing hypotheses in large numbers of patients enrolled in common protocols, answers will be provided more rapidly than by individual centers acting alone. The six clinical sites or "Reproductive Medicine Units" (RMUs) are The University of Pennsylvania in Philadelphia, Magee-Women's Hospital in Pittsburgh, Baylor College of Medicine in Houston, the University of California at Davis (with a "satellite" site at Kaiser Permanente in San Francisco), Brigham and Women's Hospital, Boston MA, and the University of Alabama at Birmingham. The Data Coordinating Center (DCC) is at Columbia University, New York City. Since the Network is supported by Cooperative Agreements, and NIH scientific staff member functions as a partner in the role of Research Coordinator. The Principal Investigators of the RMU's and DCC, the NIH Research Coordinator, and an independent Chair form the Steering Committee. The Steering Committee makes decisions by consensus, regarding topics to be studied, protocol design and execution, and publication. A Data Safety and Monitoring Committee convened by the NICHD has responsibility for reviewing clinical protocols, and for making a recommendation of the NICHD whether to accept, modify, or decline proposed studies. The first protocol is a 2x2 comparison of intrauterine vs intracervical insemination, each with or without gonadotropin stimulation of the ovaries. Couples (n=932) with an apparently normal female partner, i.e. unexplained infertility or male factor infertility, who meet the eligibility criteria will be randomized and enrolled. Ovulation induction will be carried out using Metrodin (human follitropin) under an IND. It is anticipated that Network activity will eventually encompass two simultaneous protocols, one in infertility and one in gynecology.