Luteal Progesterone Supplementation in Clomiphene Citrate-IUI Cycles

描述（由申请人提供）：俄克拉何马大学生殖内分泌学和不孕症科具有独特的定位，为生殖医学网络提供地理上独特和种族多样化的研究站点。OU-RMNU为RMN带来了一批临床科学家和医生，以及一名研究护士、一名监管专家和一名数据库管理员。这个经验丰富的团队参与了包括不明原因的不孕症、多囊卵巢综合征和女性生殖衰老的临床试验和调查。此外，我们的优势还包括我们庞大的临床业务量和在我们诊所治疗的各种生殖疾病。我们的概念提案题为“在枸橼酸克罗米芬-宫内人工授精（CC-IUI）治疗周期中补充黄体黄体酮治疗不明原因不孕症”，展示了我们部门的合作性质和我们的研究兴趣。最近的观察性和小型前瞻性研究表明，黄体期黄体酮补充可能提高不明原因不孕妇女接受超排卵-人工授精治疗的活产率。然而，所有这些调查都有方法上的弱点和不足。与体外受精相比，这些治疗的成本低，利用率高，即使是活产率的微小改善也具有临床意义。本研究的主要目的是确定黄体期补充黄体酮是否能提高接受CC-IUI治疗不明原因不孕症夫妇的活产率。次要目的包括评估与安慰剂对照组相比，接受孕酮补充治疗的妇女的临床妊娠率和自然流产率的差异。本研究将通过一项适当的多中心、安慰剂对照、双盲临床试验来解决上述问题，该试验将招募720对夫妇

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.