Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle
Infertility Unexplained · Infertility, Male · DNA Damage
Bottom Line
View on ClinicalTrials.gov: NCT03319654 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DNA fragmentation by TUNEL assay (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Antwerp
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DNA Fragmentation as a Predictor of Live Birth Rate |
32 | 0.04 sig |
| SECONDARY % SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI) |
9.6 | — |
| SECONDARY % SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI) |
0.6 | — |
| SECONDARY % SDF in the Total Fraction in the Ejaculate of the IUI- Sample |
8 | — |
| SECONDARY % SDF in the Vital Fraction in the Ejaculate of the IUI- Sample |
1 | — |
| SECONDARY % SDF in the Total Fraction After Density Gradient in the IUI Sample |
8.3 | — |
| SECONDARY % SDF in the Vital Fraction After Density Gradient in the IUI Sample |
0.4 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Couples seeking fertility treatment after at least 12 months of unprotected intercourse are eligible. All couples underwent basic fertility investigations which included semen analysis, evaluation of menstrual cycle, and tubal patency testing.
Exclusion Criteria
Double sided tubal disease, severe endometriosis (classified as revised American Society for Reproductive Medicine stage III or IV), premature ovarian failure, and known endocrine disorders (such as Cushing's syndrome or adrenal hyperplasia), azoö- or necrozoospermia
Data sourced from ClinicalTrials.gov (NCT03319654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.