Infertility, MaleNCT06050031
Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
An observational study of Infertility, Male, run by Janna Pape.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Intake of antioxidant supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Male patients with infertility
Who may be able to join
- Willing to participate
- Written consent
- Men with infertility problems who want to start an infertility treatment with their partner
Who cannot join
- No measurement of DNA fragmentation possible
- Intake of prescribed medications
- Exposure to toxins
- Chronic diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects
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.
Read the 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.
- Conditions
- Infertility, Male
- Being tested
- Intake of antioxidant supplement
- Keywords
- antioxidant, DNA-fragmentation, Oxidation-reduction potential, Lifestyle
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of antioxidant supplementDietary 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
DFI
DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)
Measured: At baseline and after three months of antioxidant-treatment
Secondary outcomes (10)
Sperm concentration
Sperm concentration [10^6/mL]
Measured: At baseline and after three months of antioxidant-treatment
Sperm motility
Total sperm progressive motility [%] Oxidation-reduction potential [mV/10-6 sperm/mL]
Measured: At baseline and after three months of antioxidant-treatment
Oxidation-reduction potential in ejaculate
Oxidation-reduction potential [mV/10-6 sperm/mL]
Measured: At baseline and after three months of antioxidant-treatment
Alcohol consumption
Alcohol consumption [unit per week]
Measured: At baseline and during the three months of antioxidant-treatment
BMI
BMI [kg/m2]
Measured: At baseline and after the three months of antioxidant-treatment
Smoking
Cigarette consumption [number of cigarettes per week]
Measured: At baseline and during the three months of antioxidant-treatment
Treatment adherence
Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study startMay 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janna Pape
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janna Pape, Universitätsklinik fur Frauenheilkunde, Inselspital Bern
- Investigators
- Michael von Wolff, Prof, Study chair, Universitätsklinik fur Frauenheilkunde, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050031
- Sponsor's protocol ID
- 2023-00611
- Other IDs
- 2023
- Status last verified
- May 2024
- First submitted
- 11 Sep 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects
- ClinicalTrials.gov ID
- NCT06050031
- Acronym / sponsor ID
- 2023-00611
- Conditions
- Infertility, Male
- Keywords
- antioxidant, DNA-fragmentation, Oxidation-reduction potential, Lifestyle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Janna PapeUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male patients with infertility
Key inclusion criteria (3 listed)
- Willing to participate
- Written consent
- Men with infertility problems who want to start an infertility treatment with their partner
Key exclusion criteria (4 listed)
- No measurement of DNA fragmentation possible
- Intake of prescribed medications
- Exposure to toxins
- Chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake of antioxidant supplementAll 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. | Dietary supplement | – |
Primary outcome
DFI
Time frame: At baseline and after three months of antioxidant-treatment
DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)
10 secondary outcomes
Sperm concentration
Time frame: At baseline and after three months of antioxidant-treatment
Sperm motility
Time frame: At baseline and after three months of antioxidant-treatment
Oxidation-reduction potential in ejaculate
Time frame: At baseline and after three months of antioxidant-treatment
Alcohol consumption
Time frame: At baseline and during the three months of antioxidant-treatment
BMI
Time frame: At baseline and after the three months of antioxidant-treatment
Smoking
Time frame: At baseline and during the three months of antioxidant-treatment
Treatment adherence
Time frame: During three months of antioxidants
Implantation rate
Time frame: 10-12 days after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Clinical pregnancy rate
Time frame: 5 weeks after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Live birth rate
Time frame: 9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael von Wolff, Prof study chair
Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male, run by Janna Pape.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janna Pape, MD (0041316321010, janna.pape@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFI (time frame: At baseline and after three months of antioxidant-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.