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

Infertility, Male Clinical Trial

Official title:

Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06050031
• Other study ID #: 2023-00611
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
• Contact: Janna Pape, MD
• Phone: 0041316321010
• Email: janna.pape[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janna Pape

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFI	DNA-fragmentation measured by sperm-chromatin-structure-assay (SCSA)	At baseline and after three months of antioxidant-treatment
Secondary	Sperm concentration	Sperm concentration [10^6/mL]	At baseline and after three months of antioxidant-treatment
Secondary	Sperm motility	Total sperm progressive motility [%] Oxidation-reduction potential [mV/10-6 sperm/mL]	At baseline and after three months of antioxidant-treatment
Secondary	Oxidation-reduction potential in ejaculate	Oxidation-reduction potential [mV/10-6 sperm/mL]	At baseline and after three months of antioxidant-treatment
Secondary	Alcohol consumption	Alcohol consumption [unit per week]	At baseline and during the three months of antioxidant-treatment
Secondary	BMI	BMI [kg/m2]	At baseline and after the three months of antioxidant-treatment
Secondary	Smoking	Cigarette consumption [number of cigarettes per week]	At baseline and during the three months of antioxidant-treatment
Secondary	Treatment adherence	Averaged missing capsules per week (100%, 75%, 50%, 25%) during treatment	During three months of antioxidants
Secondary	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
Secondary	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
Secondary	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