Efficacy of Dexamethasone in Polycystic Ovary Syndrome Related Infertility

描述（由申请人提供）：本申请是为了回应RFA-HD-13-016，作为临床研究中心参与一项正在进行的多中心合作项目，旨在开展临床研究，调查生殖医学问题。该申请直接涉及生殖科学分支的使命，即通过对人类生育力和不孕症的研究，确保出生健康、想要的婴儿。该项目的长期目标是提高多囊卵巢综合征（PCOS）不孕妇女的活产率，并探讨慢性炎症在PCOS相关不孕症的病理生理学中的作用以及对此类个体生育治疗的反应。克罗米芬的一线治疗未能使多达一半的PCOS患者成功妊娠。然而，在CC中加入地塞米松（DEX）有望成为该人群中安全，有效，廉价的干预措施。因此，我们提出以下具体的施舍：具体目标1。比较接受CC+安慰剂治疗的PCOS女性与接受CC + DEX治疗的PCOS女性的活产率;具体目标2。比较接受CC和安慰剂治疗的PCOS女性与接受CC + DEX治疗的PCOS女性的血清激素水平和炎症标志物;具体目标3。探索血清激素水平和炎症标志物或这些参数的治疗相关变化与排卵和活产率之间的可能关系。我们将通过进行一项双盲、随机试验，比较CC加DEX与CC加安慰剂诱导排卵，来解决这些具体的施舍。基于在提案中描述的考虑，我们假设：1）用CC加DEX治疗的患有PCOS的妇女的活产率将比用CC加安慰剂治疗的妇女的活产率高10%; 2）与用CC加安慰剂治疗的妇女相比，用CC加DEX治疗的受试者的硫酸脱氢表雄酮（DHEAS）和炎症标志物的血清水平将显著降低; 3）在用DEX治疗的女性中，较低水平的炎症标志物将与更高的活产可能性相关。

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.