Efficacy of Dexamethasone in Polycystic Ovary Syndrome Related Infertility

描述(由申请人提供)：本申请是为了响应RFA-HD-13-016，以临床站点的身份参与正在进行的多中心合作计划，旨在进行临床研究，调查生殖医学中的问题。该应用程序直接涉及生殖科学处的使命，即通过对人类生育和不孕不育的研究，确保健康、想要的婴儿的出生。拟议项目的长期目标是提高患有多囊卵巢综合征(PCOS)的不孕妇女的活产率，并探讨慢性炎症在PCOS相关不孕的病理生理学和对生育治疗的反应中所起的作用。克罗米芬一线治疗未能导致多达一半的多囊卵巢综合征患者成功怀孕。然而，在CC中加入地塞米松(DEX)是一种安全、有效、廉价的干预措施。因此，我们提出以下的具体措施：1.比较CC+安慰剂与CC+DEX治疗的PCOS患者的活产率；2.比较CC+安慰剂与CC+DEX治疗的PCOS患者的血清激素水平和炎症标志物水平；特殊目的3.探讨血清激素水平与炎症标志物或治疗相关指标的变化与排卵率和活产率的关系。我们将通过进行CC加DEX与CC加安慰剂的双盲随机促排卵试验来解决这些特殊的施舍问题。基于提案中描述的考虑因素，我们假设：1)接受CC+DEX治疗的PCOS妇女的活产率将比接受CC+安慰剂治疗的妇女高10%；2)与接受CC+安慰剂治疗的妇女相比，接受CC+DEX治疗的受试者的血清硫酸脱氢表雄酮(DHEAS)水平和炎症标志物水平将显著降低；3)接受DEX治疗的妇女的炎症标志物水平较低将与活产的可能性更高相关。

DESCRIPTION (provided by applicant): This application is written in response to RFA-HD-13-016 to participate as a Clinical Site in an ongoing multicenter cooperative program designed to conduct clinical studies investigating problems in reproductive medicine. The application directly addresses the mission of the Reproductive Sciences Branch to ensure the birth of healthy, wanted babies through studies on human fertility and Infertility. The long term objectives of the proposed project are to improve live birth rates in infertile women with polycystic ovary syndrome (PCOS), and to explore the role of chronic Inflammation In the pathophysiology of PCOS-related infertility and in the response to fertility therapy in such individuals. First line therapy with clomiphene citrate fails to result in successful pregnancy in up to one-half of PCOS patients. However, the addition of dexamethasone (DEX) to CC shows promise as a safe, effective, inexpensive intervention in this population. We thus propose the following specific alms: Specific Aim 1. To compare the live birth rate in women with PCOS treated with CC plus placebo to that in PCOS women treated with CC plus DEX; Specific Aim 2. To compare serum hormone levels and markers of inflammation in women with PCOS treated with CC and placebo to those in PCOS women treated with CC plus DEX; Specific Aim 3. To explore possible relationships between serum hormone levels and markers of inflammation or treatment-related changes in these parameters and ovulation and live born delivery rates. We will address these specific alms by conducting a double-blind, randomized trial of ovulation induction with CC plus DEX compared to CC plus placebo. Based on considerations described in the proposal we hypothesize that: 1) The live birth rate in women with PCOS treated with CC plus DEX will be 10% higher than the rate in women treated with CC plus placebo; 2) Serum levels of dehydroepiandrosterone sulfate (DHEAS) and markers of inflammation will be reduced significantly in subjects treated with CC plus DEX compared to women treated with CC plus placebo; 3) Lower levels of markers of inflammation in women treated with DEX will be associated with a higher likelihood of live born delivery.