Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh、Kafr el-Sheikh Governorate、埃及、33511
- Kafrelsheikh University Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
- Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles.
- Age 18 to 35 years.
- Body mass index (BMI) ≤ 30 kg/m².
- Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy.
- Partner with normal semen analysis.
- Willing and able to provide informed consent.
Exclusion Criteria:
- Thyroid dysfunction.
- Hyperprolactinemia.
- Diabetes mellitus.
- Congenital adrenal hyperplasia.
- Adrenal causes of hyperandrogenism.
- Use of insulin-sensitizing medications (e.g., metformin) during the study period.
- Chronic liver disease.
- Chronic kidney disease.
- Contraindications to pregnancy.
- Contraindications or hypersensitivity to inositol or letrozole.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Extended Letrozole Protocol (7 days
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? ELP (Extended Letrozole Protocol) Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days. Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation. When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly. Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved. |
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实验性的：Letrozole + Inositol Protocol
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? LIP (Letrozole + Inositol Protocol) Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction. In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days. Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed. Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse. Compliance with inositol intake and any adverse effects will be documented throughout the study period. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ovulation Rate
大体时间：At the end of Cycle 1 (each treatment cycle is 28 days).
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The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women.
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At the end of Cycle 1 (each treatment cycle is 28 days).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Spontaneous Ovulation Rate
大体时间：Up to 3 months after treatment initiation.
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The proportion of participants who achieve spontaneous ovulation during the study period.
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Up to 3 months after treatment initiation.
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Clinical Pregnancy Rate
大体时间：Up to 12 weeks after treatment initiation.
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The proportion of participants with clinical pregnancy confirmed by transvaginal ultrasonographic visualization of a gestational sac.
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Up to 12 weeks after treatment initiation.
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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