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

Infertile Men Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252510
• Other study ID #: CHU-0208
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: September 26, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• infertile men

• <50 years

• with at least 5.106spermatozoa/ml in the ejacu

Exclusion Criteria:

• azoospermia

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertile Men

Intervention

Other:
• HALOSPERM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)		at day 1	Yes
Secondary	Percentage of sperm DNA damage measured by TUNEL method		at day 1	Yes