Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound
研究概览
简要总结
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial. Participants and dispensing staff are not masked to treatment assignment because the two interventions differ in formulation and dosing. Investigators performing folliculometry and confirming ovulation, laboratory personnel processing progesterone and β-hCG assays, the adverse-event assessor, and the statistician are blinded to treatment assignment. Participants are instructed not to disclose their treatment regimen to outcome assessors.
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Age between 20- 38 years old.
- •Diagnosis of PCOS according to Rotterdam criteria
- •Letrozole resistant cases.
- •Normal thyroid hormone level.
- •Normal prolactin hormone level.
排除标准
- •• History of ovarian surgery.
- •cases associated with endometriosis.
- •History of diabetes mellitus.
- •Allergy to myo-Inositol .
研究组 & 干预措施
Metformin group
PhaseA( priming phase) : Metformin initiated at 500mg oral once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day Phase B(induction ) : letrozole 7.5 mg/day on cycle days 3-7 for three consecutive cycles or until clinical pregnancy Folic acid 400 µg/day is administered throughout the study.
干预措施: Metformin (Drug)
Myoinositol group
Phase A (Priming phase) : myo-inositol 2 g twice daily for 8 weeks Phase B ( ovulation induction ): letrozole 7.5 mg/day on cycle days 3-7 for up to three cycles or until clinical pregnancy. Folic acid 400 µg/day is administered throughout the study.
干预措施: Myoinositol (Drug)
结局指标
主要结局
Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound
时间窗: 5 months (8 weeks priming phase + 3 consecutive cycles of letrozole )
Cumulative Ovulation rate confirmed by folliculometry measured by transvaginal ultrasound
时间窗: 5 months after taking letrozole only for 3 month
次要结局
- * clinical pregnancy(5 months ( 8weeks of priming phase + 3 consecutive cycles of letrozole ))
研究者
Aya Mohsen Mahnoud Aboelkhier
Principal investigator
Kafrelsheikh University