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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
Sponsor:
Information provided by (Responsible Party):
Janna Pape, Universitätsklinik fur Frauenheilkunde, Inselspital Bern

Study Description
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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.

Condition or disease Intervention/treatment
Infertility, Male Dietary Supplement: Intake of antioxidant supplement

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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. DFI [ Time Frame: At baseline and after three months of antioxidant-treatment ]
    DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)


Secondary Outcome Measures :
  1. Sperm concentration [ Time Frame: At baseline and after three months of antioxidant-treatment ]
    Sperm concentration [10^6/mL]

  2. 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]

  3. Oxidation-reduction potential in ejaculate [ Time Frame: At baseline and after three months of antioxidant-treatment ]
    Oxidation-reduction potential [mV/10-6 sperm/mL]

  4. Alcohol consumption [ Time Frame: At baseline and during the three months of antioxidant-treatment ]
    Alcohol consumption [unit per week]

  5. BMI [ Time Frame: At baseline and after the three months of antioxidant-treatment ]
    BMI [kg/m2]

  6. Smoking [ Time Frame: At baseline and during the three months of antioxidant-treatment ]
    Cigarette consumption [number of cigarettes per week]

  7. Treatment adherence [ Time Frame: During three months of antioxidants ]
    Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment

  8. 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

  9. 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

  10. 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


Eligibility Criteria
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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
Study Population
Male patients with infertility
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Janna Pape, MD 0041316321010 janna.pape@insel.ch

Sponsors and Collaborators
Janna Pape
Investigators
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Study Chair: Michael von Wolff, Prof Universitätsklinik fur Frauenheilkunde, Inselspital Bern
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janna Pape, Universitätsklinik fur Frauenheilkunde, Inselspital Bern:
antioxidant
DNA-fragmentation
Oxidation-reduction potential
Lifestyle
Additional relevant MeSH terms:
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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