NCT06050031

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

September 11, 2023

Last Update Submit

May 7, 2024

Conditions

Infertility, Male

Keywords

antioxidantDNA-fragmentationOxidation-reduction potentialLifestyle

Outcome Measures

Primary Outcomes (1)

  • DFI

    DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)

    At baseline and after three months of antioxidant-treatment

Secondary Outcomes (10)

  • Sperm concentration

    At baseline and after three months of antioxidant-treatment

  • Sperm motility

    At baseline and after three months of antioxidant-treatment

  • Oxidation-reduction potential in ejaculate

    At baseline and after three months of antioxidant-treatment

  • Alcohol consumption

    At baseline and during the three months of antioxidant-treatment

  • BMI

    At baseline and after the three months of antioxidant-treatment

  • +5 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsNo, it is based on the biological gender.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male patients with infertility

You may qualify if:

  • Willing to participate
  • Written consent
  • Men with infertility problems who want to start an infertility treatment with their partner

You may not qualify if:

  • No measurement of DNA fragmentation possible
  • Intake of prescribed medications
  • Exposure to toxins
  • Chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Michael von Wolff, Prof

    Universitätsklinik fur Frauenheilkunde, Inselspital Bern

    STUDY CHAIR

Central Study Contacts

Janna Pape, MD

CONTACT

0041316321010janna.pape@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Dr. med. Janna Pape

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 22, 2023

Study Start

May 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share