TROGLITAZONE AND CLOMIPHENE FOR OVULATION INDUCTION

曲格列酮和克罗米芬用于促排卵

• 批准号: 2677526
• 负责人: NICHOLAS A CATALDO
• 金额: $ 5.28万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-01 至 1999-11-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2677526
• 关键词: clinical research; clomiphene; combination chemotherapy; female; human subject; human therapy evaluation; insulin sensitivity /resistance; ovulation; polycystic ovary syndrome; reproductive system disorder chemotherapy; troglitazone; women's health

DESCRIPTION (Adapted from applicant's description): This proposal will evaluate the effectiveness of a new drug combination for the induction of ovulation in anovulatory women with polycystic ovary syndrome (PCOS), a disorder affecting about 5% of women of reproductive age, characterized by anovulation with loss of menstrual cyclicity and hyperandrogenism, often resulting in hirsutism or acne. Induction of ovulation is necessary to restore fertility to women with PCOS and anovulation. The standard first-line treatment is with oral clomiphene citrate, an anti-estrogenic agent which increases endogenous FSH secretion. This study will examine whether clomiphene can be more effective in inducing ovulation if given concomitantly with troglitazone, an insulin sensitizer which lowers circulating insulin levels. Women with PCOS selected for previous resistance to clomiphene ovulation induction will be randomized to receive either troglitazone or placebo for a 2-month accommodation period and then will undergo attempted ovulation induction with clomiphene using standard regimens. If unsuccessful, the clomiphene dose will be increased in subsequent cycles according to standard practice in an effort to achieve ovulation. Ovulatory outcome, assessed by serum progesterone levels, will be compared between troglitazone and placebo groups and correlated with correction of hyperinsulinemia and with changes in baseline gonadotrophin, sex steroid and binding globulin (SHBG) levels.

描述（根据申请人的描述改编）：本提案将 评价一种新的药物组合用于诱导 多囊卵巢综合征（PCOS）无排卵妇女的排卵， 影响约5%育龄妇女的疾病，其特征为 无排卵伴月经周期丧失和高雄激素血症，常 导致多毛症或痤疮。 诱导排卵是必要的， 恢复PCOS和无排卵妇女的生育能力。 标准 一线治疗是口服克罗米芬，一种抗雌激素 增加内源性FSH分泌的药剂。 本研究将探讨 克罗米酚是否能更有效地诱导排卵， 同时使用曲格列酮，一种胰岛素增敏剂， 循环胰岛素水平 选择既往PCOS的女性 对克罗米酚诱导排卵有抵抗的患者将随机接受 曲格列酮或安慰剂治疗2个月，然后 将使用标准的克罗米芬进行尝试性排卵诱导 养生法 如果不成功，克罗米酚的剂量将增加， 根据标准做法， 排卵 通过血清孕酮水平评估排卵结果， 比较曲格列酮组和安慰剂组， 纠正高胰岛素血症和基线促性腺激素的变化， 性类固醇和结合球蛋白（SHBG）水平。