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NCT04183374 Clinical Trial

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

Infertility Clinical Trial

— ReproDNA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04183374
Other study ID # DFI2019Skiveintervention
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date February 1, 2025

Study information
Verified date April 2023
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 680
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - DNA fragmentation index above 15 % Exclusion Criteria: - TESA/PESA

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Life style
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation

Locations
Country Name City State
Denmark Fertility Clinic Skive, Skive Regional Hospital Skive

Sponsors (1)
Lead Sponsor Collaborator
Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in DNA fragmentation index (DFI) DFI is measured by SCSA 3-4 months after inclusion
Secondary Change in classical sperm parameters Sperm count 3-4 months after inclusion
Secondary Change in classical sperm parameters Sperm motility (movement) 3-4 months after inclusion
Secondary Change in classical sperm parameters Sperm morphology (structure) 3-4 months after inclusion
Secondary Change in classical sperm parameters Sperm concentration in mio sperm pr. milliliter 3-4 months after inclusion
Secondary Changes in parameters for metabolic syndrome Weight in kilograms 3-4 months after inclusion
Secondary Changes in parameters for metabolic syndrome Blood pressure in millimeters of mercury 3-4 months after inclusion
Secondary Changes in parameters for metabolic syndrome Hemoglobin A1c in mmol/L 3-4 months after inclusion
Secondary Changes in parameters for metabolic syndrome Body mass index in kg/m^2 3-4 months after inclusion
Secondary Change in plasma lipids Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides 3-4 months after inclusion
Secondary Change in serum D-vitamin levels 25-hydroxy vitamin D (D3+D2) measured as nmol/l 3-4 months after inclusion
Secondary 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
Secondary Number of participants with clinical pregnancy Measurement of heart beat by ultrasound scan Week 7-8 of pregnancy
Secondary Number of participants with biochemical pregnancy Increase in serum hCG levels Day 14-17 of pregnancy
Secondary Cumulative live birth rate Live births originating from one controlled stimulation. 9-24 months after inclusion
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