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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
680
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Fertility Clinic Skive, Skive Regional Hospital
Skive, Denmark
RECRUITINGChange in DNA fragmentation index (DFI)
DFI is measured by SCSA
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Sperm count
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Sperm motility (movement)
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Sperm morphology (structure)
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Sperm concentration in mio sperm pr. milliliter
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Weight in kilograms
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Blood pressure in millimeters of mercury
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Hemoglobin A1c in mmol/L
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Body mass index in kg/m\^2
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Time frame: 3-4 months after inclusion
Change in plasma lipids
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Time frame: 3-4 months after inclusion
Change in serum D-vitamin levels
25-hydroxy vitamin D (D3+D2) measured as nmol/l
Time frame: 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.
Time frame: Week 30-42 of pregnancy
Number of participants with clinical pregnancy
Measurement of heart beat by ultrasound scan
Time frame: Week 7-8 of pregnancy
Number of participants with biochemical pregnancy
Increase in serum hCG levels
Time frame: Day 14-17 of pregnancy
Cumulative live birth rate
Live births originating from one controlled stimulation.
Time frame: 9-24 months after inclusion