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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02252510

Enrollment

Registered

2014-09-30

Start date

2013-01-31

Completion date

2014-06-30

Last updated

2014-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile Men

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.

Interventions

OTHERHALOSPERM

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* azoospermia

Design outcomes

Primary

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

Secondary

Measure	Time frame
Percentage of sperm DNA damage measured by TUNEL method	at day 1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026