Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

Recruiting

• Conditions: Infertility, Male

• Registration Number: NCT05846256
• Lead Sponsor: Peter Humaidan

Brief Summary

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-25
• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-05-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 125

Inclusion Criteria

• Unexplained infertile men who will undergo 1st or 2nd IVF treatment
• Age over 18 years
• Normal sperm parameters according to WHO criteria
• IVF treatment

Exclusion Criteria

• ICSI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.	30-60 minutes	Sperm DNA Fragmentation done with a Comet Assay analysis

Secondary Outcome Measures

Name	Time	Method
The proportion of single-stranded DNA damage in sperm of men with unexplained infertility	30-60 minutes	Sperm DNA Fragmentation done with a Comet Assay analysis

Trial Locations

Locations (1)

Fertility Clinic Regional Hospital Skive; 🇩🇰 Skive, Denmark