Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
Sponsor
Peter Humaidan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05846256
Collaborator
ExamenLab Ltd (Other)
125
1
19.3
6.5
Study Details
Study Description
Brief Summary
The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
125 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
Actual Study Start Date
:
Apr 25, 2023
Anticipated Primary Completion Date
:
May 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Infertile male Men with unexplained infertility |
Other: Sperm DNA Fragmentation
Sperm DNA Fragmentation analysis.
|
| Donors (control) Fertile sperm donors |
Other: Sperm DNA Fragmentation
Sperm DNA Fragmentation analysis.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fertility Clinic Regional Hospital Skive | Skive | Denmark | 7800 |
Sponsors and Collaborators
- Peter Humaidan
- ExamenLab Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Peter Humaidan,
Professor, Consultant,
Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT05846256
Other Study ID Numbers:
- Doublestrand DNA Fragmentation
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peter Humaidan,
Professor, Consultant,
Regionshospitalet Viborg, Skive
Additional relevant MeSH terms: