NCT06050031

Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility

Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 78 (estimated)
• Sponsor: Janna Pape · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The investigators will investigate the effect of antioxidants and lifestyle factors on the level of oxidative stress. As oxidative stress cannot be directly measured, it will be approximated by the DNA fragmentation index (DFI) which reflects the level of DNA damage in sperm caused by oxidative stress.

Detailed description

This is a one-site prospective exploratory study at the University Clinic for Gynaecological Endocrinology and Reproductive Medicine in Bern. On total 78 men with male infertility will be recruited. The primary objective of the study is to assess the effectiveness of 3 months of antioxidant-based therapy on changing patients' DFI level. The objective of the study is to assess the effect of 3 months of antioxidant-based therapy on the level of DFI. We are primarily interested in testing whether the treatment effectiveness (i.e. the change in DFI level) depends on the initial level (i.e. before treatment) and treatment adherence. The data will be collected by the physicians and added to the REDcap study registry. Access to the total data set is only permitted for the principal investigator.

Conditions

• Infertility, Male

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intake of antioxidant supplement	All participants will supplent oral antioxidants (individual or combined which can be obtained without prescription, and which are not regulated as a pharmaceutical drug) over three months.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-09-22
• Last updated: 2024-05-08