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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06050031
Study type Observational
Source Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Contact Janna Pape, MD
Phone 0041316321010
Email janna.pape@insel.ch
Status Not yet recruiting
Phase
Start date May 2024
Completion date December 2025

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