In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 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 gonadotropin therapy 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 gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
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.
研究组 & 干预措施
IVF group
Women will undergo one full IVF cycle
干预措施: IVF (Procedure)
Gonadotropin group
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
干预措施: Gonadotropin (Drug)
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
- 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)
- Multifetal pregnancy rate(12 weeks gestational age)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University