Cooperative Multicenter Reproductive Medicine Network

描述（由申请人提供）：宾夕法尼亚大学在生殖内分泌学、不孕症和生殖生物学方面有着悠久的多学科临床和基础研究传统。在本申请的第一部分中，我们将提供大学在生殖医学领域的临床和研究活动的总结，回顾可用的设施，并重点介绍我们继续参与多中心工作的能力，以分析和改善不孕症管理。自17年前该网络成立以来，宾大一直是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，有两项是提出的宾夕法尼亚大学概念协议，一项在NEJM上发表，另一项在《生育与不育》杂志上发表，其中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。在目前的申请中，我们建议建立宾夕法尼亚生殖研究小组（PRReG），以改善大费城地区的研究对象招募。此外，宾夕法尼亚大学的概念方案建议测试这样一个假设，即人类胚胎在体外暴露于较低的生理性氧浓度（5%）而不是超生理性氧浓度（20% -这是标准护理）可提高活产率。这是一项随机、双盲、多中心的临床试验，基于现有的动物数据和初步的人类观察，它有可能彻底改变辅助生殖技术的实践。经过大量讨论后，决定制定一项与试管婴儿相关的协议，尽管它具有政治上的性质，但对于RMN来说是非常重要的，因为ART是当前不孕症治疗的核心，而且如果RMN在其协议中不包括试管婴儿项目，则可能被标记为“无关紧要”。按照设计，拟议的研究不使用联邦资金用于人类体外受精工作的任何方面，因此，在目前国会限制的情况下，它是合适的。我们坚信，拟议的研究完成后，对现行做法的影响将是极其重大的。鉴于过去的记录，卓越的临床研究基础设施以及在多中心临床试验的设计，招聘和分析方面的成熟专业知识，宾夕法尼亚大学RMU的成员期待着继续参与生殖医学网络。

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.