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

Completed

• Conditions: Infertile Men

• Registration Number: NCT02252510
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-26
• Last Update Submitted: 2014-09-26
• Study First Posted: 2014-09-30
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• azoospermia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)	at day 1

Secondary Outcome Measures

Name	Time	Method
Percentage of sperm DNA damage measured by TUNEL method	at day 1