Cooperative Multicenter Reproductive Medicine Network

多中心生殖医学合作网络

• 批准号: 7929908
• 负责人: Michael Peter Diamond
• 金额: $ 29.2万
• 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/7929908
• 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(由申请者提供)：我们的总体目标是改善男性和女性的生殖健康，从而促进健康、想要的孩子的出生。此次续签申请的目标是继续成为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，并提供一个庞大的患者基础(包括大量的少数民族人口)，以便将受试者登记到网络协议中。为了实现这一目标，我们建议通过记录韦恩州立大学(WSU)的一系列研究经验、专业知识和资源与成功参与RMN保持一致，通过提供WSU在合作临床研究方面的承诺和记录(特别是我们在过去七年中RMN对象登记和数据质量的历史)的证据，并通过提供“概念”协议作为我们构思和设计合作项目的能力的证明。机构和部门对RMN的支持力度很大，营造了一种支持和有利于合作临床研究的环境(包括广泛的外部资金，以及NIH内壁周围学研究处的存在)，并提供实质性支持(例如，为工资、研究活动提供资金，以及为该部门75,000平方米的1700万美元翻修提供资金)。英国《金融时报》致力于妇女生殖健康的C.S.莫特中心)。WSU RMN的关键人员每人在WSU生殖研究方面都有十年以上的经验，在NIH资助、设计和实施多中心试验以及监管审查方面有长期的记录。我们希望在其他人确定的研究中成为RMN不可或缺的、做出贡献的成员，并成为新的、具有临床意义的项目的创新者。我们将为满足我们领域中确定的主要需求作出贡献，我们的概念议定书就是例证，它处理了医学研究所关于降低多胎妊娠率的建议。我们概念方案的具体目标是确定一种能够可靠地产生排卵而不是超数排卵的药理制剂。中心假设是，在接受卵巢刺激和宫内受精的不孕妇女中，使用芳香酶抑制剂将充分刺激卵巢，不会降低怀孕率，同时显著减少因促性腺激素刺激而导致的多胎妊娠的数量。RMN对于成功完成这项议定书至关重要，以确保及时招募所需数量的受试者，以达到准确解释结果所需的足够权力。与公共卫生的相关性：WSU RMN的重新筹资将使我们能够接触到我们服务的城市人口，并允许他们得到护理。我们的概念提案的成功结果将具有重要意义，因为积极的结果将有助于降低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。