Clinical trial NCT06050031: Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
Official title: Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility: An Observational Study on Factors Influencing the Treatment Effects
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infertility, Male
Keywords: antioxidant
DNA-fragmentation
Oxidation-reduction potential
Lifestyle
Lead sponsor: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with infertility

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.

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.

Eligibility 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

Primary outcomes:
measure: DFI
timeFrame: At baseline and after three months of antioxidant-treatment
Secondary outcomes:
measure: Sperm concentration
timeFrame: At baseline and after three months of antioxidant-treatment
measure: Sperm motility
timeFrame: At baseline and after three months of antioxidant-treatment
measure: Oxidation-reduction potential in ejaculate
timeFrame: At baseline and after three months of antioxidant-treatment
measure: Alcohol consumption
timeFrame: At baseline and during the three months of antioxidant-treatment
measure: BMI
timeFrame: At baseline and after the three months of antioxidant-treatment
measure: Smoking
timeFrame: At baseline and during the three months of antioxidant-treatment
measure: Treatment adherence
timeFrame: During three months of antioxidants
measure: Implantation rate
timeFrame: 10-12 days after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
measure: Clinical pregnancy rate
timeFrame: 5 weeks after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
measure: Live birth rate
timeFrame: 9 months after timed intercourse, insemination or embryo transfer in the first treatment cycle after the antioxidant treatment
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
name: Michael von Wolff, Prof
role: STUDY_CHAIR
References: