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临床试验/NCT02058212
NCT02058212已完成2 期

Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

olfat nouh riad

assisstant professor

Cairo University

研究点 (1)

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