NCT02456792撤回4 期
In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Mohamed Sayed Abdelhafez3 个研究点 分布在 1 个国家开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Live birth rate
研究概览
简要总结
The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).
详细描述
Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.
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
- •Infertile women with PCOS as defined by the Rotterdam criteria.
- •CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
排除标准
- •Age < 20 or > 35 years.
- •Presence of any infertility factor other than anovulatory PCOS.
- •Previous history of ovarian surgery or surgical removal of one ovary.
- •Previous exposure to cytotoxic drugs or pelvic irradiation.
- •Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- •Metabolic or hormonal abnormalities.
结局指标
主要结局
Live birth rate
时间窗: 9 months
Number of live births divided by the number of women
次要结局
- Multifetal pregnancy rate(12 weeks gestational age)
- Miscarriage rate(12 weeks gestational age)
- Clinical pregnancy rate(6-8 weeks gestational age)
- Incidence of early ovarian hyperstimulation syndrome (OHSS)(Within 9 days of final triggering of oocyte maturation)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University
研究点 (3)
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