NCT03009838Unknown3 期
Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The ovulation rate
研究概览
简要总结
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.
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
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of at least one year of infertility either primary or secondary.
- •Body mass index: 25-35
- •Normal fallopian tubes
- •Normal semen analysis of the husband
- •Women who will accept to participate in the study
排除标准
- •Body mass index above 35
- •Contraindication to general anesthesia
- •Previous laparoscopic drilling
- •Presence of other causes of infertility
- •Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
- •Women who intended to start a diet program
- •Women who will refuse to participate in the study.
研究组 & 干预措施
letrozole
Active Comparator
letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day
干预措施: Letrozole (Drug)
laparoscopic drilling
Active Comparator
laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle
干预措施: ovarian drilling (Procedure)
结局指标
主要结局
The ovulation rate
时间窗: 3 months
次要结局
- The mid-cyclic endometrial thickness(one day)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )AnovulationPolycystic Ovary SyndromeNCT02551367mostafa gomaa hamid halawa110
Unknown
不适用
Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS WomenPolycystic Ovary SyndromeInfertilityNCT01793038Mansoura Integrated Fertility Center160
已完成
4 期
Combined Letrozole and Clomid in Women With Infertility and PCOSPolycystic Ovary SyndromeInfertilityNCT02802865Rachel Mejia70
Unknown
不适用
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and BerberinePolycystic Ovary SyndromeNCT01116167Heilongjiang University of Chinese Medicine660
已完成
不适用
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian SyndromePolycystic Ovary SyndromeNCT05075863Nishtar Medical University78