Our overall goal is to improve reproductive health of men and women, thereby fostering the birth of healthy, wanted children. The objective of this renewal application is to remain part of the Cooperative Multi-center Reproductive Medicine Network (RMN). We are committed to cooperative research and offer a large patient base (including a large minority population) from which to enroll subjects into Network protocols. We propose to achieve this objective by documenting that Wayne State University's (WSU) spectrum of research experience, expertise, and resources are consistent with successful participation in the RMN, by providing evidence of WSU's commitment and track record in cooperative clinical research (specifically our history of high RMN subject enrollment and data quality over the past seven years), and by providing a 'concept'protocol as proof of our ability to conceive and design a cooperative project. Institutional and departmental support for the RMN is strong, fostering an environment supportive of, and conducive for, collaborative clinical research (including extensive extramural funding, and the presence of the NIH Intramural Perinatology Research Branch) and with substantive support (e.g., funding for salaries, research activities, and $17 million renovation of the department's 75,000 sq. ft. C.S. Mott Center that is dedicated to women's reproductive health). WSU RMN key personnel each have over ten year's experience in reproductive research at WSU, with a long track record of NIH funding, design and conduct of multi-center trials, and regulatory review experience. We expect to be an integral, contributing member of the RMN in research identified by others, and an innovator of novel, clinically significant projects. We would contribute to meeting major identified needs in our field, as exemplified by our concept protocol, which addresses the Institute of Medicine's recommendation to reduce the rate of multiple gestation pregnancies. The specific objective of our concept protocol is to identify a pharmacologic agent that will reliably produce ovulation, but not super ovulation. The central hypothesis is that in infertile women undergoing ovarian stimulation and intrauterine insemination, the use of aromatase inhibitors will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the number of multiple gestational pregnancies that result from stimulation with gonadotropins. The RMN is vital to successful completion of this protocol to assure timely recruitment of the number of subjects needed to reach the sufficient power required to interpret results accurately. Relevance to Public Health: Re-funding of the WSU RMN would provide access to, and allow care for, the urban population we serve. Successful outcomes of our concept proposal would be significant because a positive result would allow reduction of the life-long morbidity and mortality of children from multiple gestational pregnancies, thereby decreasing the economic burden to these couples and society.
Showing the most recent 10 out of 50 publications
