Through this application, the University of Pennsylvania seeks to continue its participation in the network of clinical reproductive medicine units (RMU). The University has established strength in clinical and basic research in infertility, endocrinology and reproductive biology. High volume clinical programs in the surgical and medical treatment of female and male infertility have been in place for over three decades. Laboratories dedicated to reproductive medicine (assisted reproductive technologies, andrology, and reproductive endocrinology) and an NIH-supported Clinical Research Center enhance the clinical and research programs. The participating faculty brings expertise in gynecology, andrology, psychiatry, clinical epidemiology and biostatistics, clinical chemistry and computer and information technology. The proposed administrative structure for the RMU includes a Principal Investigator, Christos Coutifaris, M.D., Ph.D., Director of the Division of Reproductive Endocrinology and Infertility, who will be assisted by two co- principal investigators Luigi Mastroianni, Jr., M.D., previous director of the division and original P.I. of the Penn RMU and Kurt Barnhart, M.D., M.S.C.E., director of the division's clinical research unit. In addition, an Executive Committee will oversee the progress and functions of the RMU. During the previous period of funding, the first two clinical trials were completed and the initial analysis of the superovulation/intrauterine insemination (SO/IUI) protocol was published in the New England Journal of Medicine. Analyses of the fertile male study results and those of a number of ancillary studies stemming from the SO/IUI trial are currently being performed. If funding is extended, the University of Pennsylvania RMU will continue to recruit patients for the endometrial biopsy study (Penn's """"""""concept protocol"""""""" in the previous submission) recently approved as a Network-wide protocol and will participate in any new studies decided upon by the steering committee and NICHD. It is anticipated that two additional years will be required for completion of the endometrial biopsy study. It is also anticipated that the protocol for the use of Methotrexate for treatment of ectopic pregnancy will be implemented in all RMN sites. With the recent establishment of a clinical research unit within the Division, which has dedicated space, equipment and personnel, the Penn RMU is in the unique position to undertake and successfully participate in multiple concurrent clinical trials. It is our expectation that as the Reproductive Medicine Network has now matured, multiple protocols will successfully be implemented.
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