CLASSICAL ANTAGONIST PROTOCOL IN COMPARISON WITH AGONIST STOP PROTOCOL IN Polycystic Ovary Symdrome WOMEN UNDERGOING Intra-cytoplasmic Injection TRIAL: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The difference in clinical pregnancy rate in both groups
研究概览
简要总结
Stein and Leventhal were the first to recognize an association between the presence of polycystic ovaries and signs of hirsutism and amenorrhea (eg,oligomenorrhea, obesity), After women diagnosed with Stein-Leventhal syndrome underwent successful wedge resection of the ovaries, their menstrual cycles became regular, and they were able to conceive. As a consequence, a primary ovarian defect was thought to be the main culprit, and the disorder came to be known as polycystic ovarian disease.
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
- •Women under 35 years with polycystic ovary syndrome criteria
- •Normal male semen parameters
- •Normal tubes either by hysterosalpingography &/or laparoscopy
- •Free from other endocrine abnormalities
排除标准
- •NON polycystic ovary syndrome Criteria
- •More than 35 years
- •Abnormal semen parameters
- •Pathological tube& pelvic factor
- •Other endocrine disorders
研究组 & 干预措施
Study group
the antagonist protocol group" where they will do intra-cytoplasmic injection using classical antagonist protocol
干预措施: Cetrorelix (Drug)
control group
"agonist stop/antagonist protocol group" where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol
干预措施: Cetrorelix (Drug)
control group
"agonist stop/antagonist protocol group" where they will receive mid luteal agonist in the preceding intra-cytoplasmic injection cycle before starting classical antagonist protocol
干预措施: Leuprolide Acetate (Drug)
结局指标
主要结局
The difference in clinical pregnancy rate in both groups
时间窗: 6 weeks
ultrasound detection of fetal heart pulsations
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University