Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
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ClinicalTrials.gov Identifier: NCT06050031 |
Recruitment Status :
Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : May 8, 2024
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Condition or disease | Intervention/treatment |
---|---|
Infertility, Male | Dietary Supplement: Intake of antioxidant supplement |
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 |
Estimated Enrollment : | 78 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects |
Estimated Study Start Date : | May 2024 |
Estimated Primary Completion Date : | June 2025 |
Estimated Study Completion Date : | December 2025 |
- 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.
- DFI [ Time Frame: At baseline and after three months of antioxidant-treatment ]DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)
- Sperm concentration [ Time Frame: At baseline and after three months of antioxidant-treatment ]Sperm concentration [10^6/mL]
- Sperm motility [ Time Frame: 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 [ Time Frame: At baseline and after three months of antioxidant-treatment ]Oxidation-reduction potential [mV/10-6 sperm/mL]
- Alcohol consumption [ Time Frame: At baseline and during the three months of antioxidant-treatment ]Alcohol consumption [unit per week]
- BMI [ Time Frame: At baseline and after the three months of antioxidant-treatment ]BMI [kg/m2]
- Smoking [ Time Frame: At baseline and during the three months of antioxidant-treatment ]Cigarette consumption [number of cigarettes per week]
- Treatment adherence [ Time Frame: During three months of antioxidants ]Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment
- Implantation rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | No, it is based on the biological gender. |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050031
Contact: Janna Pape, MD | 0041316321010 | janna.pape@insel.ch |
Study Chair: | Michael von Wolff, Prof | Universitätsklinik fur Frauenheilkunde, Inselspital Bern |
Responsible Party: | Janna Pape, Principal Investigator, Dr. med. Janna Pape, Universitätsklinik fur Frauenheilkunde, Inselspital Bern |
ClinicalTrials.gov Identifier: | NCT06050031 |
Other Study ID Numbers: |
2023-00611 |
First Posted: | September 22, 2023 Key Record Dates |
Last Update Posted: | May 8, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
antioxidant DNA-fragmentation Oxidation-reduction potential Lifestyle |
Infertility Infertility, Male Genital Diseases Urogenital Diseases Genital Diseases, Male |
Male Urogenital Diseases Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |