DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health

Study Overview
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Brief Summary
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A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention.

Official Title
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DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health

Conditions
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Infertility

Intervention / Treatment
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* Other: Life style


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DNA fragmentation index above 15 % Exclusion Criteria: TESA/PESA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation | Other: Life style<br>* Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DNA fragmentation index (DFI) | DFI is measured by SCSA | 3-4 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in classical sperm parameters | Sperm count | 3-4 months after inclusion | 
| Change in classical sperm parameters | Sperm motility (movement) | 3-4 months after inclusion | 
| Change in classical sperm parameters | Sperm morphology (structure) | 3-4 months after inclusion | 
| Change in classical sperm parameters | Sperm concentration in mio sperm pr. milliliter | 3-4 months after inclusion | 
| Changes in parameters for metabolic syndrome | Weight in kilograms | 3-4 months after inclusion | 
| Changes in parameters for metabolic syndrome | Blood pressure in millimeters of mercury | 3-4 months after inclusion | 
| Changes in parameters for metabolic syndrome | Hemoglobin A1c in mmol/L | 3-4 months after inclusion | 
| Changes in parameters for metabolic syndrome | Body mass index in kg/m^2 | 3-4 months after inclusion | 
| Change in plasma lipids | Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides | 3-4 months after inclusion | 
| Change in serum D-vitamin levels | 25-hydroxy vitamin D (D3+D2) measured as nmol/l | 3-4 months after inclusion | 
| Number of participants achieving live birth | Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic. | Week 30-42 of pregnancy | 
| Number of participants with clinical pregnancy | Measurement of heart beat by ultrasound scan | Week 7-8 of pregnancy | 
| Number of participants with biochemical pregnancy | Increase in serum hCG levels | Day 14-17 of pregnancy | 
| Cumulative live birth rate | Live births originating from one controlled stimulation. | 9-24 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male infertility, DNA fragmentation Index, DFI, life style intervention