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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04183374

Acronym

ReproDNA

Enrollment

680

Registered

2019-12-03

Start date

2019-10-01

Completion date

2025-02-01

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

male infertility, DNA fragmentation Index, DFI, life style intervention

Brief 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.

Interventions

OTHERLife style

Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* DNA fragmentation index above 15 %

Exclusion criteria

* TESA/PESA

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Changes in parameters for metabolic syndrome	3-4 months after inclusion	Weight in kilograms
Change in plasma lipids	3-4 months after inclusion	Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Change in serum D-vitamin levels	3-4 months after inclusion	25-hydroxy vitamin D (D3+D2) measured as nmol/l
Change in classical sperm parameters	3-4 months after inclusion	Sperm count
Number of participants with clinical pregnancy	Week 7-8 of pregnancy	Measurement of heart beat by ultrasound scan
Number of participants with biochemical pregnancy	Day 14-17 of pregnancy	Increase in serum hCG levels
Cumulative live birth rate	9-24 months after inclusion	Live births originating from one controlled stimulation.
Number of participants achieving live birth	Week 30-42 of pregnancy	Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026