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而写的，作为临床站点参与一个正在进行的多中心合作项目，该项目旨在开展生殖医学问题的临床研究。该申请直接针对生殖科学处的任务，即通过对人类生育和不孕症的研究，确保生出健康的婴儿。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，并探讨慢性炎症在多囊卵巢综合征相关不孕的病理生理和对这些个体的生育治疗反应中的作用。一线治疗与克罗米芬柠檬酸未能导致成功怀孕的PCOS患者高达一半。然而，在CC中加入地塞米松（DEX）作为一种安全、有效、廉价的干预措施有望在这一人群中得到应用。因此，我们提出以下具体目标：比较CC +安慰剂治疗的PCOS女性与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患者与接受CC加DEX治疗的PCOS患者的血清激素水平和炎症标志物；具体目标3。探讨血清激素水平与炎症标志物或治疗相关参数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、随机试验来解决这些特定的施舍问题，将CC + DEX与CC +安慰剂进行排卵诱导试验。基于提案中所述的考虑，我们假设：1)接受CC + DEX治疗的PCOS女性的活产率将比接受CC +安慰剂治疗的女性高10%；2)与服用CC +安慰剂的女性相比，服用CC + DEX的受试者血清中硫酸脱氢表雄酮（DHEAS）和炎症标志物水平将显著降低；3)接受DEX治疗的女性炎症标志物水平较低与活产的可能性较高相关。

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.