Luteal Progesterone Supplementation in Clomiphene Citrate-IUI Cycles

描述(由申请者提供)：俄克拉荷马大学生殖内分泌学和不孕不育部分具有独特的定位，为生殖医学网络提供了一个地理上不同和种族多样的研究地点。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有关不明原因不孕症、多囊卵巢综合征和女性生殖老化的临床试验和调查。此外，我们的优势包括我们的临床体量大，以及我们诊所治疗的生殖障碍种类繁多。我们题为“克罗米芬--宫腔内人工授精(CC-IUI)治疗不明原因不孕症周期中补充黄体酮”的概念提案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，黄体期补充孕酮可能会改善接受超促排卵-IUI治疗的不明原因不孕症妇女的活产率。然而，所有这些调查都有方法上的缺陷，而且力度不够。考虑到与试管受精的成本相比，这些治疗的成本较低且利用率较高，即使是活产率的微小改善也将具有临床意义。这项研究的主要目的是确定黄体期补充孕酮是否能提高接受CC-IUI治疗的不明原因不孕症夫妇的活产率。次要目标包括评估补充黄体酮的妇女与安慰剂对照组妇女在临床妊娠率和自然流产率方面的差异。这项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。 患有不明原因的不孕症。夫妻间有效的循证治疗的识别 考虑到不孕不育给社会带来的负担，原因不明的不孕症至关重要，我直接响应NICHD的使命。

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.