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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD039005-10
Application #
8123196
Study Section
Special Emphasis Panel (ZHD1-DSR-A (08))
Program Officer
De Paolo, Louis V
Project Start
2000-06-30
Project End
2013-07-31
Budget Start
2011-08-01
Budget End
2013-07-31
Support Year
10
Fiscal Year
2011
Total Cost
$283,270
Indirect Cost
Name
Wayne State University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
Mumford, Sunni L; Legro, Richard S; Diamond, Michael P et al. (2016) Baseline AMH Level Associated With Ovulation Following Ovulation Induction in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab 101:3288-96
Hansen, Karl R; He, Amy Linnea W; Styer, Aaron K et al. (2016) Predictors of pregnancy and live-birth in couples with unexplained infertility after ovarian stimulation-intrauterine insemination. Fertil Steril 105:1575-1583.e2
Pal, Lubna; Zhang, Heping; Williams, Joanne et al. (2016) Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Clin Endocrinol Metab 101:3027-35
Legro, Richard S; Dodson, William C; Kunselman, Allen R et al. (2016) Benefit of Delayed Fertility Therapy With Preconception Weight Loss Over Immediate Therapy in Obese Women With PCOS. J Clin Endocrinol Metab 101:2658-66
Steiner, Anne Z; Diamond, Michael P; Legro, Richard S et al. (2015) Chlamydia trachomatis immunoglobulin G3 seropositivity is a predictor of reproductive outcomes in infertile women with patent fallopian tubes. Fertil Steril 104:1522-6
Kuang, Hongying; Jin, Susan; Hansen, Karl R et al. (2015) Identification and replication of prediction models for ovulation, pregnancy and live birth in infertile women with polycystic ovary syndrome. Hum Reprod 30:2222-33
Diamond, Michael P; Legro, Richard S; Coutifaris, Christos et al. (2015) Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics. Fertil Steril 103:962-973.e4
Polotsky, Alex J; Allshouse, Amanda A; Casson, Peter R et al. (2015) Impact of Male and Female Weight, Smoking, and Intercourse Frequency on Live Birth in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab 100:2405-12
Usadi, Rebecca S; Diamond, Michael P; Legro, Richard S et al. (2015) Recruitment strategies in two reproductive medicine network infertility trials. Contemp Clin Trials 45:196-200
Brower, Meredith A; Jones, Michelle R; Rotter, Jerome I et al. (2015) Further investigation in europeans of susceptibility variants for polycystic ovary syndrome discovered in genome-wide association studies of Chinese individuals. J Clin Endocrinol Metab 100:E182-6

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