Inositol in Letrozol Resistant PCOS Women
Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women
研究概览
详细说明
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age .Furthermore, impaired glucose tolerance affects 30 - 40 % of women with PCOS and the pathophysiology of insulin resistance appears to be linked to a malfunction in the insulin signalling system. Insulin-sensitizing substances, including the B-complex vitamin inositol and its stereoisomers (myo-inositol and D-chiro-inositol )have therefore been investigated as a potential treatment for PCOS.
Letrozole is the recommended medication for ovulation induction in PCOS-related infertility since it produces higher pregnancy and live birth rates than Clomphine Citrate. Alternative regimens, such as two-step, higher, and prolonged doses, may be necessary for women who are not responding to the standard letrozole dosage. However, some women might not respond to letrozole even at the highest dosage.
Inositols are produced by the human body and are a member of the vitamin B complex group.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways. They positively influence menstrual cycle regularity, carbohydrate metabolism, and the clinical and laboratory symptoms of hyperandrogenism (e.g., free testosterone, total testosterone, SHBG).
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Cairo、埃及
- Kafrelshiekh 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:
• Age between 20- 38 years old.
- Diagnosis of PCOS according to Rotterdam criteria
- Letrozole resistant cases.
- Normal thyroid hormone level.
- Normal prolactin hormone level.
Exclusion Criteria:
• History of ovarian surgery.
- cases associated with endometriosis.
- History of diabetes mellitus.
- Allergy to myo-Inositol .
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 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 |
|---|---|
|
有源比较器:Myoinositol group
Combined myoinositol twice daily for 3 months plus letrozole
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Combined myoinositol & Dchiroinositol twice daily plus letrozole for 3 months
|
|
有源比较器:Metformin group
Metformin 500mg oral twice daily plus letrozole for 3 months
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Metformin 500mg twice daily plus letrozole for 3 months
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Cumulative Ovulation rate confirmed by folliculometry measured by transvaginal ultrasound
大体时间:5 months after taking letrozole only for 3 month
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5 months after taking letrozole only for 3 month
|
合作者和调查者
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KFSIRB200-600
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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