Cooperative Multicenter Reproductive Medicine Network

多中心生殖医学合作网络

• 批准号: 7935602
• 负责人: CHRISTOS COUTIFARIS
• 金额: $ 31.85万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7935602
• 关键词: Affect; Air; Area; Assisted Reproductive Technology; Basic Science; Birth Rate; Caring; Charge; Clinical; Clinical Research; Clinical Trials; Data; Data Set; Development; Double-Blind Method; Embryo; Embryo Loss; Embryo Transfer; Environment; Exposure to; Fertility; Fertilization in Vitro; Funding; Hamsters; Human; In Vitro; Incubators; Infertility; Intervention; Investigation; Journals; Label; Laboratories; Leadership; Life; Live Birth; Macaca mulatta; Mammalian Oviducts; Measurement; Multi-Institutional Clinical Trial; Multiple Pregnancy; Nature; Oryctolagus cuniculus; Oxidative Stress; Oxygen; Oxygen measurement, partial pressure, arterial; Pennsylvania; Philadelphia; Physiological; Play; Pregnancy Rate; Protocols documentation; Publications; Publishing; Randomized; Randomized Controlled Trials; Registries; Reproductive Biology; Reproductive Endocrinology; Reproductive Medicine; Research; Research Activity; Research Infrastructure; Role; Simulate; Spontaneous abortion; Sterility; Study Subject; Testing; Universities; Uterus; Woman; Work; animal data; base; design; egg; embryo culture; exposed human population; improved; in vivo; interest; member; multidisciplinary; prospective; reproductive; standard of care; success

DESCRIPTION (provided by applicant): The University of Pennsylvania reflects a long tradition of multidisciplinary clinical and basic research in reproductive endocrinology, infertility, and reproductive biology. In the first sections of this application, we will provide a summary of the University's clinical and research activities in the area of reproductive medicine, review the available facilities, and focus on our capability to continue to participate in multi-center efforts to analyze and improve infertility management. The Penn RMU has been part of the RMN since the Network's inception over seventeen years ago and has played a leadership role in the design, implementation, analysis and publication of many of the RMN's studies. Specifically, of the three major studies the RMN has completed to date, two have been the proposed Penn concept protocols, one resulting in a NEJM publication and the second resulting in three Fertility and Sterility publications comprising the centerpiece of a Controversies section of the journal. These contributions have resulted in a change of the standard of care. In the present application, we propose the establishment of the Penn Reproductive Research Group (PRReG) in order to improve study subject recruitment in the greater Philadelphia area. In addition, the Penn concept protocol proposes to test the hypothesis that exposure of human embryos in vitro to reduced, more physiologic (5%) rather than supraphysiologic (20% - which is the standard of care) oxygen concentration improves live born rates. This is a randomized, double blind, multi-center clinical trial, which has the potential, based on existing animal data and preliminary human observations, to revolutionize the practice of assisted reproductive technologies. Following significant discussion, it was decided that an IVF- related protocol, in spite its politically charged nature, would be very important for the RMN to undertake since ART is central to current infertility treatments and since the RMN could be labeled "irrelevant" if it did not include an IVF project among its protocols. As designed, the proposed study does not utilize federal funds for any aspects of the human IVF work and, as such, makes it appropriate in the presence of current congressional restrictions. We strongly believe, that upon completion of the proposed study, the impact on current practice will be extremely significant. Given the track record, excellence of the clinical research infrastructure and the proven expertise in the design, recruitment and analysis of multi-center clinical trials, the members of the Penn RMU are looking forward to continue their participation in the Reproductive Medicine Network.

描述（由申请人提供）：宾夕法尼亚大学反映了生殖内分泌学，不孕症和生殖生物学多学科临床和基础研究的悠久传统。在本申请的第一部分，我们将提供该大学在生殖医学领域的临床和研究活动的总结，审查可用的设施，并专注于我们继续参与多中心努力分析和改善不孕不育管理的能力。宾夕法尼亚大学RMU自17年前RMN成立以来一直是RMN的一部分，并在RMN的许多研究的设计，实施，分析和出版中发挥了领导作用。具体来说，在RMN迄今为止完成的三项主要研究中，有两项是拟议的Penn概念方案，一项导致NEJM出版物，第二项导致三篇生育和不育出版物，包括该杂志争议部分的核心内容。这些贡献导致了护理标准的改变。在本申请中，我们建议建立宾夕法尼亚生殖研究组（PRReG），以改善大费城地区的研究受试者招募。此外，Penn概念方案提出测试以下假设：体外人类胚胎暴露于降低的、更生理（5%）而不是超生理（20% -这是护理标准）氧浓度可提高活产率。这是一项随机、双盲、多中心的临床试验，根据现有的动物数据和初步的人体观察，有可能彻底改变辅助生殖技术的实践。经过大量讨论，决定IVF相关方案，尽管其具有政治上的性质，但对于RMN来说将是非常重要的，因为ART是当前不孕症治疗的核心，并且如果RMN在其方案中不包括IVF项目，则RMN可能被标记为“无关紧要”。按照设计，拟议的研究不利用联邦资金用于人类试管婴儿工作的任何方面，因此，在当前国会限制的情况下，它是适当的。我们坚信，在拟议的研究完成后，对现行做法的影响将极其重大。鉴于其良好的临床研究基础设施以及在多中心临床试验的设计、招募和分析方面的专业知识，宾夕法尼亚大学RMU的成员期待着继续参与生殖医学网络。