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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06050031
Other study ID # 2023-00611
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date December 2025

Study information

Verified date May 2024
Source Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Contact Janna Pape, MD
Phone 0041316321010
Email janna.pape@insel.ch
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 78
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Janna Pape

Outcome

Type Measure Description Time frame Safety issue
Primary DFI DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA) At baseline and after three months of antioxidant-treatment
Secondary Sperm concentration Sperm concentration [10^6/mL] At baseline and after three months of antioxidant-treatment
Secondary Sperm motility Total sperm progressive motility [%] Oxidation-reduction potential [mV/10-6 sperm/mL] At baseline and after three months of antioxidant-treatment
Secondary Oxidation-reduction potential in ejaculate Oxidation-reduction potential [mV/10-6 sperm/mL] At baseline and after three months of antioxidant-treatment
Secondary Alcohol consumption Alcohol consumption [unit per week] At baseline and during the three months of antioxidant-treatment
Secondary BMI BMI [kg/m2] At baseline and after the three months of antioxidant-treatment
Secondary Smoking Cigarette consumption [number of cigarettes per week] At baseline and during the three months of antioxidant-treatment
Secondary Treatment adherence Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment During three months of antioxidants
Secondary Implantation rate Endocrine pregnancy by measuring hCG in blood sample on day 10-12 after timed intercourse, insemination or embryo transfer 10-12 days after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Secondary Clinical pregnancy rate Clinical pregnancy confirmed by ultrasound, 5 weeks after timed intercourse, insemination or embryo transfer 5 weeks after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Secondary Live birth rate Birth of a living baby nine months after timed intercourse, insemination or embryo transfer 9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
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