Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility

NCT ID: NCT06050031

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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

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Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janna Pape

OTHER

Sponsor Role lead

Responsible Party

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Janna Pape

Principal Investigator, Dr. med. Janna Pape

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael von Wolff, Prof

Role: STUDY_CHAIR

Universitätsklinik fur Frauenheilkunde, Inselspital Bern

Central Contacts

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Janna Pape, MD

Role: CONTACT

0041316321010

Other Identifiers

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2023-00611

Identifier Type: -

Identifier Source: org_study_id

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