Infertility, Male Clinical Trial
Official title:
Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.
| Status | Recruiting |
| Enrollment | 125 |
| Est. completion date | December 1, 2024 |
| Est. primary completion date | May 1, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Fertility Clinic Regional Hospital Skive | Skive |
| Lead Sponsor | Collaborator |
|---|---|
| Peter Humaidan | ExamenLab Ltd |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of double-stranded DNA damage in sperm of men with unexplained infertility. | Sperm DNA Fragmentation done with a Comet Assay analysis | 30-60 minutes | |
| Secondary | The proportion of single-stranded DNA damage in sperm of men with unexplained infertility | Sperm DNA Fragmentation done with a Comet Assay analysis | 30-60 minutes |
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