A Randomized Trial of Letrozole vs Clomiphene in Infertile Women with PCOS

来曲唑与克罗米芬治疗 PCOS 不孕女性的随机试验

基本信息

批准号：
7918745
负责人：
RICHARD S. LEGRO
金额：
$ 29.3万
依托单位：
PENNSYLVANIA STATE UNIV HERSHEY MED CTR
依托单位国家：
美国
项目类别：
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/7918745
关键词：
Abortion Rates Addendum Alleles Ancillary Study Andrology Anovulation Aromatase Inhibitors Assisted Reproductive Technology Birth Rate Blinded Caring Clinical Clinical Research Clomiphene Clomiphene Citrate Complication Data Disease Doctor of Medicine Doctor of Philosophy Double-Blind Method Effectiveness Endometrial Etiology Evaluation Failure Female Female infertility Fertility Fertilization Fetal Growth Fetus Funding Future Genes Genetic Health Hyperandrogenism Indium Infertility Inositol Laboratories Lead Letrozole Live Birth Male Infertility Medical Medicine Metformin Multiple Pregnancy Operative Surgical Procedures Outcome Pharmaceutical Preparations Pharmacogenetics Phase II Clinical Trials Polycystic Ovary Syndrome Predictive Factor Pregnancy Pregnancy Complications Pregnancy Rate Pregnancy loss Pregnant Women Principal Investigator Productivity Protocols documentation Publishing Randomized Recruitment Activity Relative (related person)Reproductive Endocrinology Reproductive Medicine Research Research Personnel Risk Safety Science Selective Estrogen Receptor Modulators Site Structure Subfecundity Syndrome United States National Institutes of Health Universities Urology Woman abortion anastrozole arm base clinical care college comparative efficacy comparative trial experience implantation primary outcome programs randomized trial reproductive response secondary outcome trial comparing

项目摘要

DESCRIPTION (provided by applicant): This is a competing renewal of the Penn State College of Medicine RMN Unit. We have contributed significantly to the productivity of the RMN in the prior funding cycle as a major recruiting site and developer of protocols. Dr. Legro's concept protocol from that cycle was prioritized as the first study to be undertaken, and he became the Lead Investigator of the completed Pregnancy in Polycystic Ovary Syndrome Study (PPCOS), as well as a pharmacogenetic addendum. These findings will have a marked impact on the treatment of women with PCOS. The University and Department have strengths in reproductive and clinical research that enhance the RMN unit at this site. Additionally clinical programs in the surgical and medical treatment of female and male infertility are well established and interlinked. Laboratories dedicated to reproductive medicine (assisted reproductive technologies, andrology, and reproductive endocrinology) and an NIH-supported Clinical Research Center enhance the clinical and research programs. The proposed administrative structure for the RMN Unit includes a Principal Investigator, Richard S. Legro, M.D. Director of the Division of Reproductive Endocrinology Research, A Co-Investigator with expertise in Male Infertility, J.C. Trussell, from the Division of Urology, and a Biostatistician with expertise in statistical genetics, Gary Chase, Ph.D, from the Department of Health Evaluation Sciences. In this cycle we plan to complete ancillary studies and sub-analyses from the PPCOS study as well as materially contribute to all new protocols and we anticipate that the redesigned RMN will now be able to conduct multiple protocols concurrently. We propose a concept protocol, which builds on the findings and experience garnered in PPCOS, and propose a double blind randomized two armed trial of clomiphene citrate vs. letrozole in infertile women with PCOS to establish superiority in terms of the primary outcome of live birth as well as to delineate the safety profile of the two drugs. We will also explore secondary important outcomes such as multiple pregnancy, abortion rates, pregnancy complications, and predictive factors including candidate response gene alleles. These studies are essential to establishing safe and efficacious treatments for anovulatory infertility, contributing to understanding of response mechanisms, and realistically are only likely to be conducted with the support of NIH given the involvement of pregnant women and fetuses.

描述（由申请人提供）：这是宾夕法尼亚州立医学院RMN单位的竞争续约。作为主要招聘站点和协议的开发商，我们在先前的资金周期中为RMN的生产率做出了重大贡献。 Legro博士从该周期中的概念方案优先考虑为第一项研究，他成为多囊卵巢综合征研究（PPCOS）的完成妊娠的主要研究者，以及一项药物遗传学附录。这些发现将对PCOS女性的治疗产生明显影响。大学和系具有生殖和临床研究方面的优势，可增强该站点的RMN单位。此外，在女性和男性不育症的手术和医学治疗中的临床方案还建立了良好的建立和相互联系。致力于生殖医学的实验室（辅助生殖技术，雄激素和生殖内分泌学）和NIH支持的临床研究中心增强了临床和研究计划。 RMN单元的拟议行政结构包括一名主要研究者，理查德·莱格罗（Richard S.在这个周期中，我们计划从PPCOS研究中完成辅助研究和子分析，并为所有新方案做出重大贡献，我们预计重新设计的RMN现在将能够同时执行多个方案。我们提出了一项概念方案，该协议以PPCO中获得的发现和经验为基础，并提出了一项双盲随机两次随机两次武装试验，对PCOS的不育女性的Clomiphene柠檬酸盐与LeTrozole进行了两次武装试验，以在活产的主要结果以及两种药物的安全性概况的主要结果方面建立优越性。我们还将探讨次要重要结果，例如多重妊娠，堕胎率，妊娠并发症和预测因素，包括候选反应基因等位基因。这些研究对于建立安全有效的不孕症，有助于理解反应机制的安全有效治疗至关重要，并且鉴于孕妇和胎儿的参与，现实情况下才有可能在NIH的支持下进行。