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临床试验/NCT03898752
NCT03898752已完成不适用

Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Peter Humaidan2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Oxidative stress

研究概览

简要总结

In this study we aim to investigate whether a 3-month life-style intervention would reduce oxidative stress (OS) in semen in men of infertile couples attending IVF-treatment. Men with a DFI above 15% (SCSA method) are recruited for intervention with a 3-month follow-up.

It is hypothesized that men who also have a OS above 1.34 using a novel OS diagnostic method (MiOXSYS) respond better to antioxidant treatment with a change in OS and DFI. The primary outcome is the change in OS following the intervention. Secondary outcomes are morphological semen parameters and DNA fragmentation index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Attending IVF treatment for unknown or male factor infertility.

排除标准

  • Genetic diseases
  • Azospermia

结局指标

主要结局

Oxidative stress

时间窗: 3 months

Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).

次要结局

  • Semen quality(3 months)
  • DNA fragmentation index(3 months)

研究者

发起方
Peter Humaidan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter Humaidan

Professor, MD

Regionshospitalet Viborg, Skive

研究点 (2)

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