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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05846256

Enrollment

125

Registered

2023-05-06

Start date

2023-04-25

Completion date

2024-12-01

Last updated

2023-05-06

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

Conditions

Infertility, Male

Keywords

Sperm DNA Fragmentation, Lifestyle, Doublestrand DNA Fragmentatio

Brief summary

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

Interventions

OTHERSperm DNA Fragmentation

Sperm DNA Fragmentation analysis.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Denmark

Contacts

Primary ContactPeter Humaidan, Professor

peter.humaidan@midt.rm.dk78445760

Backup ContactMette Jensen, Research assistant

mejen8@rm.dk78445718

Outcome results

None listed

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