Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Sperm cell concentration
研究概览
简要总结
Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.
详细描述
Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1 year of infertility
- •> 10 mill/ml of sperms
- •Motility < 60% progressive
- •Morphology < 2% (WHO 2010)
排除标准
- •No meeting the inclusion criteria.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
2g DHA/day
2g DHA/day
干预措施: DHA (Dietary Supplement)
1g DHA/day
1g DHA/day
干预措施: DHA (Dietary Supplement)
500 mg DHA/day
500 mg DHA/day
干预措施: DHA (Dietary Supplement)
结局指标
主要结局
Sperm cell concentration
时间窗: Three months
Measured in millions of sperm cells per ml of semen sample
Sperm cell morphology
时间窗: Three
Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.
Sperm cell motility
时间窗: Three months
Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).
次要结局
未报告次要终点