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临床试验/NCT02252510
NCT02252510已完成不适用

Evaluation of the Reliability for the Measurement of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)

University Hospital, Clermont-Ferrand0 个研究点目标入组 40 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)

研究概览

简要总结

It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This measurement helps to better diagnose male infertility and seems easy to apply in routine. However, the reliability of this method needs to be evaluated before applying for clinical practice in andrology laboratory.

详细描述

The aim of this study is to measure the inter and intra-observer reliability for the measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling) method. However, this method is not easy to apply in routine. Therefore we investigate to analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • infertile men
  • <50 years
  • with at least 5.106spermatozoa/ml in the ejacu

排除标准

  • azoospermia

结局指标

主要结局

- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)

时间窗: at day 1

次要结局

  • Percentage of sperm DNA damage measured by TUNEL method(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

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