NCT04500743已完成不适用
Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial
National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- the number of retrieved oocytes
研究概览
简要总结
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.
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
- 30 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •confirmed diagnosis of endometriosis
- •body mass index < 35 Kg/m2
排除标准
- •if they have been already on long-term down-regulation of the pituitary gland with GnRHa for control of endometriosis
- •liver or kidney disease
- •evidence of diminished ovarian reserve (e.g. high FSH level >12 IU/L or low AMH level <1 ng/ml).
研究组 & 干预措施
Dienogest
Active Comparator
干预措施: Dienogest (Drug)
GnRH analogue
Active Comparator
干预措施: leuprorelin acetate (Drug)
结局指标
主要结局
the number of retrieved oocytes
时间窗: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness
次要结局
- the fertilization rate(After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest))
- the number of transferrable embryos(After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest))
- the cost of the treatment(After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest))
- pregnancy rate per cycle started(After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest))
- the clinical pregnancy rate per cycle started(after women have postive pregnancy test (2 weeks after after the embryo transfer))
- the miscarriage rate(After occurence of the clinical pregnancy (5 months after after the embryo transfer))
- patient's quality of life(throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months")
研究者
Mazen Abdel Rasheed
Principal Investigator
National Research Centre, Egypt
研究点 (1)
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