NCT02140398Unknown4 期
Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- live birth rate per woman randomized
研究概览
简要总结
Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.
详细描述
Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
- •Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
- •Patent Fallopian tubes as confirmed by hysterosalpingography
- •Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).
排除标准
- •women with BMI >30,
- •age < 18 years or > 39 years,
- •women with ovarian cysts identified by transvaginal ultrasound
- •male factor infertility
- •Tubal factor infertility as suggested by hystrosalpingogram (HSG)
- •Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.
结局指标
主要结局
live birth rate per woman randomized
时间窗: 15 months
次要结局
- pregnancy rate per woman randomised(6 months)
研究者
研究点 (2)
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