GHSU/WSU Cooperative Reproductive Medicine Network

描述(由申请人提供)：佐治亚健康科学大学/韦恩州立大学合作续签申请的总体目标是改善男性和女性的生殖健康，从而促进健康、理想的孩子的出生。为了实现这一目标，申请者提议继续向生殖医学网络(RMN)提供广泛的研究、专门知识和资源。其中包括对合作临床研究的承诺和跟踪记录-例如，RMN指导和咨询委员会在过去五年中批准的三项方案，以及受试者登记的出色记录。这两家机构共同提供了一个特别大的患者基础(包括极高比例的少数族裔)，以便将受试者登记到新的和正在进行的网络协议中。建议的支持期的概念方案源于最近对RMN的多囊卵巢综合征妊娠研究数据的二次分析，在该研究中，申请者确定了一个新的结果：与没有接受孕激素治疗的无排卵妇女相比，在服用生育药物之前诱发孕激素停用出血的标准临床实践显著降低了受孕率和活产率。鉴于这一明确的观察，设计了一项创新的研究，以利用它。中心假设是，服用孕激素导致停药出血将对既往有无排卵周期的世卫组织第二类妇女的活产结局产生不利影响。为了验证这一假设，我们将追求三个具体目标：1)确定接受克罗米芬(CC)治疗的妇女的活产率，无论是否预先停用孕激素；2)同时确定这些妇女的怀孕时间；以及3)确定停用孕激素对黄体期激素环境和子宫内膜的影响。预期的结果是，延长我们在该网络的成员资格将使我们能够继续为该小组的合作项目作出贡献，并创新新的研究项目，供该小组审议。再加上我们扩大的城乡联合人口、在RMN试验中作为不同种族患者的主要招聘者的记录、遵守方案的出色历史、RMN结果的口头和书面传播的良好历史以及对初级临床研究人员的指导和培训的个性化关注，这些预计将对该网络实现其确定和/或改进生殖医学问题的诊断和治疗解决方案的目标的能力产生重大积极影响。

DESCRIPTION (provided by applicant): The overall goal of this collaborative Georgia Health Sciences University/Wayne State University renewal submission is to improve the reproductive health of men and women, thereby fostering the birth of healthy, desired children. To achieve this goal the applicants propose to continue to contribute a broad spectrum of research expertise and resources to the Reproductive Medicine Network (RMN). These include a commitment to and track record in cooperative clinical research - e.g., three protocols approved by the RMN Steering and Advisory Committees over the past five years, as well as a superior record of subject enrollment. The two institutions collectively offer an especially large patient base (including an extraordinarily high percentage of minorities) from which to enroll subjects into new and ongoing Network protocols. The concept protocol for the proposed period of support stems from recent secondary analysis of data from the RMN's Pregnancy in Polycystic Ovary Syndrome study, in which the applicants identified a novel outcome: the standard clinical practice of inducing a progestin-withdrawal bleed prior to administration of fertility medications dramatically decreased conception and live birth rates, compared to anovulatory women not treated with progestins. In view of this clear-cut observation, an innovative study has been designed to capitalize on it. The central hypothesis is that progestin administration to induce a withdrawal bleed will have a detrimental effect on live birth outcome in WHO Category II women with a prior anovulatory cycle. To test this hypothesis, we will pursue three specific aims: 1) Determine the rate of live births among such women receiving clomiphene citrate (CC), with or without preceding progestin withdrawal; 2) Concomitantly determine the time to pregnancy in such women; and 3) Determine the influence of progestin withdrawal on the luteal phase hormonal milieu and the endometrium. The expected outcome is that renewal of our membership in the Network would allow continued contribution to the group's cooperative projects, as well as innovation of new research projects for consideration by the group. Coupled with our enlarged joint rural and urban population, documentation of being a major recruiter of racially diverse patients in RMN trials, stellar history of protocol compliance, strong history of oral and written dissemination of RMN results, and personalized attention to mentorship and training of junior clinical investigators, these are expected to have significant positive impact o the Network's capacity to attain its goal of identifying and/or improving diagnostic and therapeutic solutions to problems in reproductive medicine.