Cooperative Multicenter Reproductive Medicine Network

描述（由申请人提供）：我们的总体目标是改善男性和女性的生殖健康，从而促进生育健康的儿童。此更新申请的目的是保持合作多中心生殖医学网络（RMN）的一部分。我们致力于合作研究，并提供大量的患者基础（包括大量的少数民族人群），从中招募受试者进入网络协议。为了实现这一目标，我们建议通过证明韦恩州立大学（WSU）的研究经验、专业知识和资源与成功参与RMN相一致，提供WSU在合作临床研究中的承诺和记录的证据（特别是我们在过去七年中高RMN主题入学率和数据质量的历史）。通过提供一个“概念”协议来证明我们有能力构思和设计一个合作项目。机构和部门对RMN的支持是强有力的，营造了一个支持和有利于合作临床研究的环境（包括广泛的校外资金，以及NIH校内围产期研究分部的存在），并提供实质性支持(例如，为工资，研究活动提供资金，并为该部门的75,000平方英尺进行了1700万美元的翻新。（C.S.莫特中心，致力于妇女生殖健康）。WSU RMN的主要人员都在WSU有超过十年的生殖研究经验，在NIH的资助、多中心试验的设计和实施以及监管审查经验方面有着长期的记录。我们期望成为RMN中不可或缺的一员，在他人确定的研究中做出贡献，并成为新颖的，具有临床意义的项目的创新者。我们将有助于满足本领域已确定的主要需求，我们的概念方案就是例证，该方案解决了医学研究所关于减少多胎妊娠率的建议。我们的概念方案的具体目标是确定一种药物，将可靠地产生排卵，但不是超排卵。中心假设是，在接受卵巢刺激和宫内人工授精的不孕妇女中，使用芳香化酶抑制剂将充分刺激卵巢而不降低妊娠率，同时显著减少促性腺激素刺激导致的多胎妊娠的数量。RMN对于成功完成本方案至关重要，以确保及时招募所需的受试者数量，以达到准确解释结果所需的足够功率。与公共卫生的相关性：重新资助城市人口管理网络将使我们所服务的城市人口能够接触到并得到照顾。我们的概念建议的成功结果将是重要的，因为一个积极的结果将能够减少多胎妊娠儿童的终生发病率和死亡率，从而减轻这些夫妇和社会的经济负担。

DESCRIPTION (provided by applicant): 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.