NCT01846325已完成2 期
The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
National Nutrition and Food Technology Institute0 个研究点目标入组 180 人开始时间: 2013年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 主要终点
- sperm motility
研究概览
简要总结
Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and filling out the informed consent form
- •should be infertile (no conception after 12 months intercourse without any contraception)
- •age 20-45 y.o, idiopathic asthenospermia according to WHO criteria
- •normal hormonal profile
排除标准
- •any infection in genitourinary (GU) tract
- •any anatomical abnormality in GU tract
- •any chronic disease during last 3 months
- •any surgery in GU tract
- •consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months
结局指标
主要结局
sperm motility
时间窗: 12 weeks
spermatogram
次要结局
- sperm count(12 weeks)
- seminal oxidative stress(12 weeks)
研究者
Dr Azita Hekmatdoost
Dr
National Nutrition and Food Technology Institute
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