NCT04183374

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

5.3 years

First QC Date

November 8, 2019

Last Update Submit

April 26, 2023

Conditions

Infertility

Keywords

male infertilityDNA fragmentation IndexDFIlife style intervention

Outcome Measures

Primary Outcomes (1)

  • Change in DNA fragmentation index (DFI)

    DFI is measured by SCSA

    3-4 months after inclusion

Secondary Outcomes (14)

  • Change in classical sperm parameters

    3-4 months after inclusion

  • Change in classical sperm parameters

    3-4 months after inclusion

  • Change in classical sperm parameters

    3-4 months after inclusion

  • Change in classical sperm parameters

    3-4 months after inclusion

  • Changes in parameters for metabolic syndrome

    3-4 months after inclusion

  • +9 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Life style

Interventions

Life styleOTHER

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

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DNA fragmentation index above 15 %

You may not qualify if:

  • TESA/PESA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic Skive, Skive Regional Hospital

Skive, 7800, Denmark

RECRUITING

MeSH Terms

Conditions

InfertilityInfertility, Male

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2019

First Posted

December 3, 2019

Study Start

October 1, 2019

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)