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.
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 Type
OBSERVATIONAL
Enrollment
78
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.
DFI
DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)
Time frame: At baseline and after three months of antioxidant-treatment
Sperm concentration
Sperm concentration \[10\^6/mL\]
Time frame: At baseline and after three months of antioxidant-treatment
Sperm motility
Total sperm progressive motility \[%\] Oxidation-reduction potential \[mV/10-6 sperm/mL\]
Time frame: At baseline and after three months of antioxidant-treatment
Oxidation-reduction potential in ejaculate
Oxidation-reduction potential \[mV/10-6 sperm/mL\]
Time frame: At baseline and after three months of antioxidant-treatment
Alcohol consumption
Alcohol consumption \[unit per week\]
Time frame: At baseline and during the three months of antioxidant-treatment
BMI
BMI \[kg/m2\]
Time frame: At baseline and after the three months of antioxidant-treatment
Smoking
Cigarette consumption \[number of cigarettes per week\]
Time frame: At baseline and during the three months of antioxidant-treatment
Treatment adherence
Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment
Time frame: During three months of antioxidants
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Implantation rate
Endocrine pregnancy by measuring hCG in blood sample on day 10-12 after timed intercourse, insemination or embryo transfer
Time frame: 10-12 days after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Clinical pregnancy rate
Clinical pregnancy confirmed by ultrasound, 5 weeks after timed intercourse, insemination or embryo transfer
Time frame: 5 weeks after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Live birth rate
Birth of a living baby nine months after timed intercourse, insemination or embryo transfer
Time frame: 9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment