Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Sperm DNA fragmentation
研究概览
简要总结
Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.
详细描述
Male patients will be recruited based on having a high DNA fragmentation (chromatin >16) no other severe male factor infertility (>5million/ml, count, > 10%motility and >1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI
排除标准
- •Severe male factor infertility
结局指标
主要结局
Sperm DNA fragmentation
时间窗: 12 weeks
Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure
次要结局
未报告次要终点