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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility, Male

Intervention / Treatment
-----------------
* Dietary Supplement: Intake of antioxidant supplement


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antioxidant, DNA-fragmentation, Oxidation-reduction potential, Lifestyle