Cooperative Multicenter Reproductive Medicine Network (U10)

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DESCRIPTION (provided by applicant): There has been a long standing research and clinical collaboration between Urology and Reproductive Endocrinology at the University of Michigan. This proposal describes the qualifications and experience of the Reproductive Endocrinology and Urology faculty as a clinical research team at the jointly supported Center for Reproductive Medicine (CRM). We outline the tremendous experience of the research staff, and detail the patient population available for carrying out clinical protocols to be designed by the NICHD Reproductive Medicine Unit (RMU) Network. The University of Michigan CRM includes 8 clinicians, who are board certified in Obstetrics and Gynecology, Reproductive Endocrinology or Urology. Working within the Center is a well qualified doctoral epidemiologist and biostatistician and 3 research nurses led by our research nurse coordinator with over 10 years experience in protocol development and implementation available for RMU network protocols. This research team has successfully completed an extensive number of randomized and non randomized clinical trials, some of which were supported by NIH grant support as well as multi-center randomized trials supported by pharmaceutical companies. Faculty in the Center for Reproductive Medicine have extensive translational and clinical research experience in areas of interest to the Network including infertility, andrology, abnormal uterine bleeding, endometriosis, leiomyomata uteri, polycystic ovarian syndrome, and assisted reproductive technology. Six faculty members are currently supported or funded by the NIH in patient oriented research. We bring to the RMU network the full support of the NIH supported General Clinical Research Center, the Departments of Obstetrics and Gynecology and Urology at the University of Michigan and the Women's Program at the Ann Arbor VA Medical Center. A concept protocol is included which proposes to investigate the effect of corrective varicocele surgery in men with an abnormal semen analysis. This trial compares the effectiveness of surgical treatment versus observation to achieve a spontaneous pregnancy or with the aid of intrauterine insemination. It is proposed that varicocele surgery will clearly benefit couples with infertility when the male partner has an abnormal semen analysis and a palpable varicocele. In summary, the research team at the Center for Reproductive Medicine is experienced in multi-center clinical trials and is committed to collaborative protocol development and study consistent with the goals of the RMU network.