Impact of sperm DNA damage on male infertility treatments

DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome

Observational Regionshospitalet Viborg, Skive · NCT04160208

This study looks at how damage to sperm DNA affects the success of fertility treatments like IVF and IUI in men trying to conceive.

Quick facts

Study typeObservational
Enrollment1350 (estimated)
Ages18 Years and up
SexMale
SponsorRegionshospitalet Viborg, Skive Academic / other
Locations1 site (Skive)
Trial IDNCT04160208 on ClinicalTrials.gov

What this trial studies

This observational study examines men undergoing assisted reproductive technology (ART) treatments such as IUI, IVF, and ICSI in Denmark. It focuses on assessing how sperm DNA damage, quantified by the DNA fragmentation index (DFI), influences reproductive outcomes. The study aims to provide insights into the relationship between DNA integrity and the success rates of these fertility treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are men undergoing their first cycle of ART treatment for infertility.

Not a fit: Patients who have undergone multiple ART cycles or require surgical sperm retrieval methods like TESA/PESA may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help improve ART outcomes for men with infertility by identifying the role of sperm DNA damage.

How similar studies have performed: Other studies have explored the impact of sperm DNA integrity on ART outcomes, suggesting that this approach has potential for meaningful insights.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* First cycle treatment

Exclusion Criteria:

* TESA/PESA, more than one cycle

Where this trial is running

Skive

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Infertilitymale infertilityDNA fragmentation IndexDFI
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.