Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,184
- 主要终点
- Time interval between surgery and natural pregnancy
研究概览
简要总结
This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.
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 patients
- •Endometriosis I-II phase：according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996
- •BMI:19-28 kg/㎡
- •Ovarian reserve function is normal（M2-5：bilateral antral follicles≥6 FSH：5-12U/ml）
排除标准
- •Male factor causes infertility
- •hydrosalpinx or salpingemphraxis
- •Uterine malformation
- •Uterine cavity lesion
- •Contra-indications for GnRH-a
- •not willing to participate
研究组 & 干预措施
GnRH-a
patients treated with GnRH-a after surgery and Outpatient guidance
.
干预措施: Goserelin Acetate (Drug)
结局指标
主要结局
Time interval between surgery and natural pregnancy
时间窗: 18 month after surgery
Time interval between surgery and natural pregnancy
Cumulative pregnancy rate
时间窗: 18 month after surgery
Cumulative pregnancy rate of 18 month after surgery
miscarriage rate
时间窗: 18 month after surgery
miscarriage rate of patients who get natural pregnancy
次要结局
未报告次要终点
研究者
Yu xiaoming
Clinician from Department of reproductive medicine.Secretary general of Fallopian tube group,Society for reproductive surgery
Peking University People's Hospital