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（改编自申请人的描述）：该提案将 评估新药物组合诱导的有效性 患有多囊卵巢综合症（PCOS）的无排卵女性的排卵 影响约 5% 育龄妇女的疾病，其特征是 不排卵，伴有月经周期丧失和雄激素过多症，通常 导致多毛症或痤疮。 诱导排卵是必要的 恢复患有多囊卵巢综合症和无排卵的女性的生育能力。 标准 一线治疗是口服克罗米芬柠檬酸盐，这是一种抗雌激素药物 增加内源性 FSH 分泌的药物。 这项研究将考察 如果给予克罗米芬是否可以更有效地诱导排卵 与曲格列酮（一种胰岛素增敏剂）合用，可降低 循环胰岛素水平。 患有 PCOS 的女性被选为以前的 对克罗米芬促排卵有抵抗力的患者将随机接受 使用曲格列酮或安慰剂进行 2 个月的住宿期，然后 将使用标准的克罗米芬尝试诱导排卵 治疗方案。 如果不成功，克罗米芬剂量将在 根据标准实践进行后续循环，以努力实现 排卵。 通过血清黄体酮水平评估排卵结果 在曲格列酮组和安慰剂组之间进行比较并与 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。