Cooperative Multicenter Reproductive Medicine Network

多中心生殖医学合作网络

• 批准号: 7673459
• 负责人: Michael Peter Diamond
• 金额: $ 29.5万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-30 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7673459
• 关键词: Address; Aromatase Inhibitors; Birth; Caring; Child; Child Mortality; Clinical Research; Commit; Couples; Data Quality; Economic Burden; Enrollment; Environment; Extramural Activities; Fostering; Funding; Goals; Gonadotropins; Human Resources; Infertility; Institute of Medicine (U.S.); Life; Minority; Morbidity - disease rate; Outcome; Ovarian Stimulations; Ovary; Ovulation; Patients; Perinatology; Population; Pregnancy; Pregnancy Rate; Protocols documentation; Public Health; Recommendation; Recording of previous events; Reproductive Health; Reproductive Medicine; Research; Research Activity; Resources; Societies; United States National Institutes of Health; Universities; Urban Population; Wages; Woman; base; clinically significant; design; experience; improved; intrauterine insemination; meetings; member; men; novel; reproductive; square foot

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.

描述（由申请人提供）：我们的总体目标是改善男性和女人的生殖健康，从而促进健康，通缉的孩子的诞生。此更新应用的目的是保留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（包括少数族裔人口），从中将受试者纳入网络协议。我们建议通过记录韦恩州立大学（WSU）的研究经验，专业知识和资源的范围，与成功参与RMN的范围是一致的，它提供了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的高RMN主题和数据质量的历史），并通过一个协议来证明一个概念的概念，并将其作为“概念”的证明。机构和部门对RMN的支持很强，促进了协作性临床研究的支持和有利于协作性临床研究（包括广泛的壁外资金，以及NIH壁内生周期研究分支机构的存在），并在实质性的支持下（例如，薪资，研究活动，1700万美元的妇女对妇女的薪资，均为75,000 Sq。生殖健康）。 WSU RMN关键人员各自拥有十年以上在WSU的生殖研究经验，其NIH资金，设计和行为多中心试验以及监管审查经验的长期记录。我们期望成为其他人确定的研究中不可或缺的RMN成员，也是新颖，具有临床意义的项目的创新者。我们将为满足我们领域的主要确定需求做出贡献，这是我们概念方案的例证，该协议涉及医学研究所的建议，以降低多重妊娠怀孕的速度。我们概念方案的具体目标是确定可以可靠地产生排卵但不能超级排卵的药理剂。中心假设是，在接受卵巢刺激和宫内授精的不育妇女中，使用芳香酶抑制剂将充分刺激卵巢，从而无法降低妊娠率，同时显着减少了由于肿瘤蛋白刺激而导致的多重妊娠妊娠的数量。 RMN对于成功完成该协议至关重要，以确保及时募集获得准确解释结果所需的足够功率所需的受试者数量。与公共卫生有关：重新资助WSU RMN将为我们服务的城市人口提供并允许关心。我们的概念提案的成功结果将是重要的，因为积极的结果将使多种妊娠怀孕的儿童终身发病率和死亡率降低，从而减轻了这些夫妇和社会的经济负担。