Luteal Progesterone Supplementation in Clomiphene Citrate-IUI Cycles

克罗米芬-IUI 周期中补充黄体孕酮

基本信息

批准号：
8585992
负责人：
Karl Richard Hansen
金额：
$ 22.16万
依托单位：
UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-24 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8585992
关键词：
Abortion Rates Address Aging Birth Rate Clinic Clinical Clinical Research Clinical Trials Clomiphene Citrate Couples Databases Disease Double-Blind Method Endometrial Enrollment Estradiol Etiology Evidence based treatment Fertility Fertilization in Vitro Future Goals Gonadotropins Human Resources Infertility Insemination Investigation Live Birth Luteal Phase Measures Mission Multiple Pregnancy Nature Nursing Research Oklahoma Ovarian Pattern Physicians Placebo Control Placebos Positioning Attribute Pregnancy Pregnancy Outcome Pregnancy Rate Principal Investigator Progesterone Prospective Studies Protocols documentation Qualifying Randomized Recruitment Activity Reproductive Endocrinology Reproductive Medicine Research Research Personnel Resistance Resources Risk Sampling Scientist Serum Serum Markers Site Societies Specialist Spontaneous abortion Superovulation Supplementation Syndrome Thick Time Training Programs Transvaginal Ultrasound Universities Vascular Endothelial Growth Factors Woman arm biobank blocking factor cost data management design effective therapy experience improved indexing interest intrauterine insemination meetings member proliferative phase Menstrual cycle public health relevance radial artery reproductive research study

项目摘要

DESCRIPTION (provided by applicant): The University of Oklahoma Section of Reproductive Endocrinology and Infertility is uniquely positioned to provide a geographically distinct and ethnically diverse study site for the Reproductive Medicine Network. The OU-RMNU brings a cadre of clinician scientists and physicians to the RMN as well as a research nurse, a regulatory specialist and a database manager. This experienced team has been involved in clinical trials and investigations involving unexplained infertility, polycystic ovarian syndrome, and reproductive aging in women. In addition, our strengths include our large clinical volume and the wide variety of reproductive disorders treated in our clinic. Our concept proposal titled "Luteal Progesterone Supplementation in Clomiphene Citrate-lntrauterine Insemination (CC-IUI) Treatment Cycles for Unexplained Infertility" provides a demonstration of the collaborative nature of our section and our research interests. Recent observational and small prospective studies have suggested that luteal phase progesterone supplementation may improve live-birth rates in women with unexplained infertility undergoing superovulation-IUI treatments. However, all of these investigations have methodological weaknesses and are underpowered. Given the low cost and high utilization of these treatments as compared to the cost of IVF, even small improvements in live-birth rates would be clinically meaningful. The primary goal of this investigation is to determine whether progesterone supplementation in the luteal phase improves the live-birth rate in couples undergoing treatment with CC-IUI for unexplained infertility. Secondary aims include evaluating differences in clinical pregnancy and spontaneous abortion rates in women treated with progesterone supplementation compared to women in the placebo control. This investigation will address the above questions with an appropriately powered multicenter, placebo-controlled, double-blinded clinical trial that will enroll 720 couples with unexplained infertility. The identification of effective evidence-based treatments for couples with unexplained infertility is vitally important given the burden of infertility on society, and i directly responsive to the NICHD's mission.

描述（由申请人提供）：俄克拉荷马大学生殖内分泌学和不育科的独特位置，可以为生殖医学网络提供一个地理上不同和种族上不同的研究地点。 OU-RMNU将临床医生和医生的干部带给了RMN，以及研究护士，监管专家和数据库经理。这个经验丰富的团队参与了涉及女性的不孕，多囊卵巢综合征和生殖老化的临床试验和调查。此外，我们的优势包括大量的临床量和我们诊所中治疗的多种生殖疾病。我们的概念提案为“补充柠檬酸克罗米芬柠檬酸含量的孕激素的孕酮（CC-IUI）治疗周期，用于无法解释的不育””，提供了我们部分协作性质和我们的研究兴趣的证明。最近的观察和小型前瞻性研究表明，补充黄体期孕激素可以提高接受超排卵治疗的不孕症的女性的活产率。但是，所有这些调查都有方法论上的弱点，并且能力不足。鉴于与IVF的成本相比，这些处理的低成本和高利用率，即使是临床有意义的，即使是生命率的较小改善也是有意义的。这项调查的主要目的是确定黄体期补充孕酮是否可以改善接受CC-IUI治疗的夫妻的活率，以至于无法解释的不育。次要目的包括评估与安慰剂对照中的女性相比，接受孕激素治疗的女性的临床妊娠和自发流产率的差异。这项调查将通过适当动力的多中心，安慰剂对照，双盲临床试验来解决上述问题，该试验将注册720对夫妇有无法解释的不育。确定有效的夫妻基于证据的治疗鉴于不孕的负担对社会的负担，用无法解释的不孕症至关重要，而且我直接回应了NICHD的使命。