Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- plasma reactive oxygen species affection by antioxidant treatment
研究概览
简要总结
ROS plays an essential role in the pathogenesis of many reproductive processes. High follicular fluid ROS levels are associated with negative IVF outcomes.
is plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?
详细描述
Study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient Participants/materials, setting, methods: was done in the Egyptian centre for IVF from March 2013 to October 2013 . 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients with endometriosis
排除标准
- •patients with no endometriosis , not suitable for ICSI-
研究组 & 干预措施
no antioxidant , ROS , pregnancy outcome
no anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF
干预措施: ascorbate 1000mg, vitamin E 400, zinc and selenium (Drug)
antioxidant , ROS , pregnancy outcome
anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)
干预措施: ascorbate 1000mg, vitamin E 400, zinc and selenium (Drug)
结局指标
主要结局
plasma reactive oxygen species affection by antioxidant treatment
时间窗: 3 months
measure before and 3months after antioxidant treatment
次要结局
- clinical pregnancy rate(2 months)
研究者
olfat nouh riad
assisstant professor
Cairo University
