Luteal Progesterone Supplementation in Clomiphene Citrate-IUI Cycles

描述（由申请人提供）：俄克拉荷马州大学生殖内分泌学和不孕不育科具有独特的优势，可以为生殖医学网络提供地理上独特的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涉及不明原因不孕症、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数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“黄体Progesterone补充克罗米芬柠檬酸盐宫内授精（CC-IUI）治疗周期不明原因不孕症”提供了我们的部分和我们的研究兴趣的协作性质的示范。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提高不明原因不孕妇女接受超排卵IUI治疗的活产率。然而，所有这些调查都存在方法上的缺陷，而且力度不够。鉴于与IVF成本相比，这些治疗的成本低，利用率高，即使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在黄体期补充孕酮是否能改善接受CC-IUI治疗不明原因不孕症的夫妇的活产率。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临床妊娠率和自然流产率的差异。本研究将通过一项具有适当把握度的多中心、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 原因不明的不孕症为夫妇确定有效的循证治疗方法 考虑到不孕症给社会带来的负担，治疗不明原因不孕症是至关重要的，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.