Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 11 With and Without Suppression by Dienogest
试验速览
- 阶段
- 4 期
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This study aims at investigating the fertility outcome of endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in endometriosis patients stage I and II.
详细描述
Study population: Sample size:
Group sample sizes of this study is 155 in group one and 155 in group two achieve 80% power to detect a difference between the group proportions of 0.10. The proportion in group one (the treatment group) is assumed to be 0.1000 under the null hypothesis and 0.2000 under the alternative hypothesis. The proportion in group two (the control group) is 0.1000. The test statistic used is .the one-sided Z test with un pooled variance. The significance level of the test was targeted at 0.05
Primary outcome:
Clinical pregnancy rate in endometriosis patients stage I and II undergoing endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month.
Secondary outcome:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women recruited in this study will have the have- a definitive diagnosis of endometriosis grade I or grade II via laparoscopy just before randomization.
排除标准
- •Male factor.
- •Other factors e.g. mullerian duct anomalies, hydrosalpinx.
- •Age > 35 years.
- •Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/1.
研究组 & 干预措施
Group A
patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2
干预措施: Dienogest 2mg (Drug)
Group A
patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2
干预措施: Clomiphene citrate 5 mg (Drug)
group B
patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2
干预措施: Clomiphene citrate 5 mg (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 2 months
fetal life detected by ultrasound
次要结局
- Ovulation rate(up to 21 days)
研究者
Alhassan Mohammad Khedr
principal investigator
Ain Shams University