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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility, Male
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 78

Contacts and Locations

• Study Contact: Name: Janna Pape, MD; Phone Number: 0041316321010; Email: janna.pape@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients with infertility

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFI	DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)	At baseline and after three months of antioxidant-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm concentration	Sperm concentration [10^6/mL]	At baseline and after three months of antioxidant-treatment
Sperm motility	Total sperm progressive motility [%] Oxidation-reduction potential [mV/10-6 sperm/mL]	At baseline and after three months of antioxidant-treatment
Oxidation-reduction potential in ejaculate	Oxidation-reduction potential [mV/10-6 sperm/mL]	At baseline and after three months of antioxidant-treatment
Alcohol consumption	Alcohol consumption [unit per week]	At baseline and during the three months of antioxidant-treatment
BMI	BMI [kg/m2]	At baseline and after the three months of antioxidant-treatment
Smoking	Cigarette consumption [number of cigarettes per week]	At baseline and during the three months of antioxidant-treatment
Treatment adherence	Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment	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	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	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	9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment

Collaborators and Investigators

• Sponsor: Janna Pape
• Investigators: Study Chair: Michael von Wolff, Prof, Universitätsklinik fur Frauenheilkunde, Inselspital Bern

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: antioxidant; Lifestyle; Oxidation-reduction potential; DNA-fragmentation
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 2023-00611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No