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

Janna Pape

Status: Not yet enrolling

Conditions: Infertility, Male

Treatments: Dietary Supplement: Intake of antioxidant supplement

Study type: Observational

Funder types: Other

Identifiers

NCT06050031

2023-00611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to participate
• Written consent
• Men with infertility problems who want to start an infertility treatment with their partner

Exclusion criteria

• No measurement of DNA fragmentation possible
• Intake of prescribed medications
• Exposure to toxins
• Chronic diseases