Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants who develop ovarian hyperstimulation syndrome
研究概览
简要总结
montelukast & dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.
详细描述
patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then montelukast & dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS high responders high numbers of ovum retrieved
排除标准
- •hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
研究组 & 干预措施
control
dydrgesterone 10 mg( tab)/12hs/14 days
干预措施: dydrgesterone 10 mg( tab)/12hs/14 days (Drug)
study
montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
干预措施: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days (Combination Product)
结局指标
主要结局
Number of Participants who develop ovarian hyperstimulation syndrome
时间窗: 0-14 days
incidence
次要结局
- Number of Participants treated of ovarian hyperstimulation syndrome(0-14 days)
研究者
Ahmed Saad
Assistant professor of Ob. & Gyn.
Benha University