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

Regionshospitalet Viborg, Skive

Status: Enrolling

Conditions: Infertility

Treatments: Other: Life style

Study type: Interventional

Funder types: Other

Identifiers

NCT04183374

DFI2019Skiveintervention

Details and patient eligibility

About

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.

Enrollment: 680 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DNA fragmentation index above 15 %

Exclusion criteria

• TESA/PESA

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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680 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Other: Life style