Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
Study Details
Study Description
Brief 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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- DFI [At baseline and after three months of antioxidant-treatment]
DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)
Secondary Outcome Measures
- Sperm concentration [At baseline and after three months of antioxidant-treatment]
Sperm concentration [10^6/mL]
- Sperm motility [At baseline and after three months of antioxidant-treatment]
Total sperm progressive motility [%] Oxidation-reduction potential [mV/10-6 sperm/mL]
- Oxidation-reduction potential in ejaculate [At baseline and after three months of antioxidant-treatment]
Oxidation-reduction potential [mV/10-6 sperm/mL]
- Alcohol consumption [At baseline and during the three months of antioxidant-treatment]
Alcohol consumption [unit per week]
- BMI [At baseline and after the three months of antioxidant-treatment]
BMI [kg/m2]
- Smoking [At baseline and during the three months of antioxidant-treatment]
Cigarette consumption [number of cigarettes per week]
- Treatment adherence [During three months of antioxidants]
Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment
- Implantation rate [10-12 days after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment]
Endocrine pregnancy by measuring hCG in blood sample on day 10-12 after timed intercourse, insemination or embryo transfer
- Clinical pregnancy rate [5 weeks after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment]
Clinical pregnancy confirmed by ultrasound, 5 weeks after timed intercourse, insemination or embryo transfer
- Live birth rate [9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment]
Birth of a living baby nine months after timed intercourse, insemination or embryo transfer
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing to participate
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Written consent
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Men with infertility problems who want to start an infertility treatment with their partner
Exclusion Criteria:
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No measurement of DNA fragmentation possible
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Intake of prescribed medications
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Exposure to toxins
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Chronic diseases
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Janna Pape
Investigators
- Study Chair: Michael von Wolff, Prof, Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-00611