Cooperative Multicenter Reproductive Medicine Network

描述（由申请人提供）：这份竞争性更新提案描述了密歇根大学生殖医学网络（RMN）网站的成就，以及由生殖内分泌学、泌尿学、医学内分泌学和生物统计学合作教师组成的研究团队的资格和经验。密歇根大学生殖医学中心包括6名委员会认证的妇产科、生殖内分泌学或泌尿学临床医生。中心内的合作伙伴是一位拥有20多年临床试验经验的生物统计学家和2个医学内分泌学院系，他们提供肥胖和代谢方面的专业知识以及独特的代谢组学研究资源。我们与密歇根州立大学合作，作为临床试验注册的辅助站点，将主题集水区扩展到密歇根州西部和北部以及周边各州。在之前的资助期内，密歇根大学网站积极参与了四项临床方案的制定、选择、设计和审查，建立了RMN组织和DNA库以及出生结果数据库。该大学还在男性不育症的评估和治疗方面发挥了领导作用，招募并指导了一名临床研究/生殖科学家培训（CREST）学者，以开发一个成功的辅助招聘网站，并为许多RMN手稿和委员会做出了贡献。我们为RMN带来了美国国立卫生研究院支持的密歇根临床研究单位、密歇根营养肥胖研究中心和密歇根区域综合代谢组学资源核心的宝贵资源，以及密歇根大学妇产科、泌尿科、代谢、内分泌和糖尿病科和安娜堡VA医学中心妇女项目的全力支持。此外，密歇根州立大学还提供了其全州范围内的妇产科、众多大学研究核心以及在妇女健康方面进行临床试验的经验的全力支持。该概念方案解决了与肥胖相关的排卵功能障碍相关的不孕不育的治疗。该研究调查了孕前剧烈减肥对生殖结果和对克罗米芬柠檬酸盐的反应的影响，并评估了预处理或治疗引起的临床或代谢组学改变是否能预测生殖结果。总之，密歇根大学生殖医学中心及相关中心和部门的研究人员为开展多中心临床试验提供了无与伦比的环境。大学已经成为当前RMN的有效站点，并已做好充分准备，在这一重要计划的下一阶段招募，参与和领导RMN活动。

DESCRIPTION (provided by applicant): 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 faculties 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, te 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 fll breath of RMN activities in the next stage of this important program.