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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intake of antioxidant supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| DFI | DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA) | At baseline and after three months of antioxidant-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm concentration | Sperm concentration [10^6/mL] | At baseline and after three months of antioxidant-treatment |
| Sperm motility | Total sperm progressive motility [%] Oxidation-reduction potential [mV/10-6 sperm/mL] |
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Inclusion Criteria:
Exclusion Criteria:
No, it is based on the biological gender.
Male patients with infertility
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janna Pape, MD | Contact | 0041316321010 | janna.pape@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Michael von Wolff, Prof | Universitätsklinik fur Frauenheilkunde, Inselspital Bern | Study Chair |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| At baseline and after three months of antioxidant-treatment |
| Oxidation-reduction potential in ejaculate | Oxidation-reduction potential [mV/10-6 sperm/mL] | At baseline and after three months of antioxidant-treatment |
| Alcohol consumption | Alcohol consumption [unit per week] | At baseline and during the three months of antioxidant-treatment |
| BMI | BMI [kg/m2] | At baseline and after the three months of antioxidant-treatment |
| Smoking | Cigarette consumption [number of cigarettes per week] | At baseline and during the three months of antioxidant-treatment |
| Treatment adherence | Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment | During three months of antioxidants |
| 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 |
| 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 |
| 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 |
| D052801 |
| Male Urogenital Diseases |