NCT04183374招募中不适用
DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health
Regionshospitalet Viborg, Skive2 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2019年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 680
- 试验地点
- 2
- 主要终点
- Change in DNA fragmentation index (DFI)
研究概览
简要总结
A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DNA fragmentation index above 15 %
排除标准
- •TESA/PESA
结局指标
主要结局
Change in DNA fragmentation index (DFI)
时间窗: 3-4 months after inclusion
DFI is measured by SCSA
次要结局
- Cumulative live birth rate(9-24 months after inclusion)
- Changes in parameters for metabolic syndrome(3-4 months after inclusion)
- Change in plasma lipids(3-4 months after inclusion)
- Number of participants achieving live birth(Week 30-42 of pregnancy)
- Change in serum D-vitamin levels(3-4 months after inclusion)
- Change in classical sperm parameters(3-4 months after inclusion)
- Number of participants with clinical pregnancy(Week 7-8 of pregnancy)
- Number of participants with biochemical pregnancy(Day 14-17 of pregnancy)
研究者
Peter Humaidan
Professor
Regionshospitalet Viborg, Skive
研究点 (2)
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