This competitive renewal proposal describes the accomplishments of the University of Michigan Reproductive Medicine Network (RMN) site and the qualifications and experience of the research team comprised of collaborative faculty from Reproductive Endocrinology, Urology, Medical Endocrinology, and Biostatistics. The University of Michigan Center for Reproductive Medicine includes 6 Board Certified clinicians in Obstetrics and Gynecology, Reproductive Endocrinology or Urology. Collaborating within the Center is a biostatistician~with over 20 years of clinical trials experience and 2 Medical Endocrinology faculty who provide expertise on obesity and metabolism and unique metabolomics research resources. We have partnered with Michigan State University to serve as an Ancillary Site for enrollment into clinical trials extending the subject catchment areas to Western and Northern Michigan and surrounding states. In the previous funding period, The University of Michigan site participated actively in the inception, selection, design, and review of four clinical protocols, the establishment of the RMN tissue and DNA repositories and birth outcomes database. The University also provided leadership in the evaluation and treatment of male infertility, recruited and mentored a Clinical Research/Reproductive Scientist Training (CREST) scholar to develop a successful ancillary recruitment site, and contributed to numerous RMN manuscripts and committees. We bring to the RMN the valuable resources of the NIH supported Michigan Clinical Research Unit, Michigan Nutrition Obesity Research Center, and Michigan Regional Comprehensive Metabolomics Resource Core, as well as the full support of the Departments of Obstetrics and Gynecology, Department of Urology, and Division of Metabolism, Endocrinology and Diabetes at the University of Michigan and the Women's Program at the Ann Arbor VA Medical Center. In addition, Michigan State University brings full support of its statewide Department of Ob/Gyn, numerous University Research cores, and experience in conducting clinical trials in women's health. The concept protocol addresses treatment of infertility associated with obesity-related ovulatory dysfunction. It investigates the impact of intensive preconceptual weight loss on reproductive outcomes and response to clomiphene citrate, and assesses if pretreatment or treatment-induced alteration in clinical or metabolomics profiles predicts reproductive outcomes. In summary, the research investigators at the University of Michigan Center for Reproductive Medicine and associated Centers and Departments provide an unparalleled environment to perform multicenter clinical trials. The University has been an effective site in the current RMN, and is fully prepared to recruit, participate, and lead in the full breath of RMN activities in the next stage of this important program.

Public Health Relevance

The Cooperative Reproductive Medicine Network (RMN) provides a consortium to perform well designed clinical trials in reproductive medicine, addressing both male and female reproductive issues. In our concept proposal, we address the reproductive abnormalities associated with obesity and propose to study the success of aggressive, short-term weight loss in the treatment of infertility.

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 #
2U10HD055936-06
Application #
8588688
Study Section
Special Emphasis Panel (ZHD1-DSR-L (55))
Program Officer
De Paolo, Louis V
Project Start
2007-08-24
Project End
2015-06-30
Budget Start
2013-09-24
Budget End
2014-06-30
Support Year
6
Fiscal Year
2013
Total Cost
$15,550
Indirect Cost
$5,550
Name
University of Michigan Ann Arbor
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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Legro, Richard S; Brzyski, Robert G; Diamond, Michael P et al. (2014) The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial. Fertil Steril 101:258-269.e8
Trussell, J C; Ohl, Dana A; Krawetz, Stephen A et al. (2014) We need a prospective varicocelectomy trial. Fertil Steril 101:1563-4.e1
Legro, Richard S; Brzyski, Robert G; Diamond, Michael P et al. (2014) Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med 371:119-29
Legro, Richard S; Kunselman, Allen R; Brzyski, Robert G et al. (2012) The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome. Contemp Clin Trials 33:470-81
Diamond, Michael P; Kruger, Michael; Santoro, Nanette et al. (2012) Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome. Obstet Gynecol 119:902-8
Will, Matthew A; Swain, Jason; Fode, Mikkel et al. (2011) The great debate: varicocele treatment and impact on fertility. Fertil Steril 95:841-52
Krawetz, Stephen A; Casson, Peter R; Diamond, Michael P et al. (2011) Establishing a biologic specimens repository for reproductive clinical trials: technical aspects. Syst Biol Reprod Med 57:222-7
Trussell, J C; Christman, Gregory M; Ohl, Dana A et al. (2011) Recruitment challenges of a multicenter randomized controlled varicocelectomy trial. Fertil Steril 96:1299-305
Schlaff, William D; Zhang, Heping; Diamond, Michael P et al. (2011) Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertil Steril 96:15-8

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