NCT02621125撤回不适用
Fertilix Supplements and Assisted Reproductive Technology
University Reproductive Associates2 个研究点 分布在 1 个国家开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Reduction in sperm DNA damage
研究概览
简要总结
This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with a sperm sample containing 8-OHdG levels > 15% and must be capable of producing an ejaculate containing >10million sperm upon study enrollment.
- •Male is between 20-55 years of age seeking treatment for infertility with his partner at URA and who is a candidate for an IUI, IVF or IVF-ICSI (excluding donor egg) procedure.
- •Female is between 20-42 years of age
- •Female exhibits tubal patency on hydrosonogram or hysterosalpingogram (HSG)
- •Female exhibits normal uterine cavity by hysteroscopy, hydrosonogram or hysterosalpingogram (HSG).
排除标准
- •Subjects with initial semen analysis of an ejaculate containing < 10 million sperm.
- •Men who have been taking nutraceuticals, vitamins or other compounds known to have antioxidant activities within4 weeks of the study. No other supplements may be taken with Fertilix.
- •Men who have hypersensitivity or an allergy to any of the ingredients in Fertilix®.
- •Men who have been treated with a chemotherapeutic agent known to cause sterility, such as cyclophosphamide.
- •Men who have taking anabolic steroids or testosterone replacement within 4 months of the study.
- •Men currently being treated with a Ca++ channel blocker or other medical treatment known to adversely affect sperm production or function.
- •Men with HIV, hepatitis B and C.
结局指标
主要结局
Reduction in sperm DNA damage
时间窗: 2 years
次要结局
未报告次要终点
研究者
Peter McGovern, MD
Principal Investigator
University Reproductive Associates
研究点 (2)
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