Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- pregnancy rate
研究概览
简要总结
The purpose of this study is to determine whether pre-treatment with danazol for at least 4 months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.
详细描述
Endometriosis is a chronic benign disease defined by the presence of endometrial tissue outside the uterine cavity, affecting women in their reproductive age. This disease is clinically characterized by infertility pelvic pain and the presence of ovarian cysts, endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the diseases and often to ovarian surgery. The aim of this study is to evaluate if a pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles in these women
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility
排除标准
- •age more than 40 years systemic disease antimulleran hormone (AMH)<1 and FSH>20
研究组 & 干预措施
control
patients treated with placebo for at least 4 months before IVF attempt
干预措施: placebo (Drug)
danazol
patients treated with danazol (100mg/day)for at least 4 months before IVF attempt
干预措施: Danazol (Drug)
结局指标
主要结局
pregnancy rate
时间窗: 12 months
number of ongoing pregnancy for the number of IVF cycles
次要结局
- implantation rate(12 months)
研究者
Fabio Scarpellini
Investigator
Centre for Endocrinology and Reproductive Medicine, Italy