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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life style | Other | Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DNA fragmentation index (DFI) | DFI is measured by SCSA | 3-4 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in classical sperm parameters | Sperm count | 3-4 months after inclusion |
| Change in classical sperm parameters | Sperm motility (movement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Clinic Skive, Skive Regional Hospital | Recruiting | Skive | 7800 | Denmark |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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| 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 |