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

University Hospital, Clermont-Ferrand40 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Infertile Men

Interventions

HALOSPERMOTHER

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * infertile men * \<50 years * with at least 5.106spermatozoa/ml in the ejacu Exclusion Criteria: * azoospermia

Outcomes

Primary Outcomes

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

Time frame: at day 1

Secondary Outcomes

Percentage of sperm DNA damage measured by TUNEL method

Time frame: at day 1

Data from ClinicalTrials.gov

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