NCT05846256

Brief Summary

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.

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
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 26, 2023

Last Update Submit

April 26, 2023

Conditions

Infertility, Male

Keywords

Sperm DNA FragmentationLifestyleDoublestrand DNA Fragmentatio

Outcome Measures

Primary Outcomes (1)

  • The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.

    Sperm DNA Fragmentation done with a Comet Assay analysis

    30-60 minutes

Secondary Outcomes (1)

  • The proportion of single-stranded DNA damage in sperm of men with unexplained infertility

    30-60 minutes

Study Arms (2)

Infertile male

Men with unexplained infertility

Other: Sperm DNA Fragmentation

Donors (control)

Fertile sperm donors

Other: Sperm DNA Fragmentation

Interventions

Sperm DNA FragmentationOTHER

Sperm DNA Fragmentation analysis.

Donors (control)Infertile male

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men with unexplanied infertility undergoing fertility treatment

You may qualify if:

  • Unexplained infertile men who will undergo 1st or 2nd IVF treatment
  • Age over 18 years
  • Normal sperm parameters according to WHO criteria
  • IVF treatment

You may not qualify if:

  • \- ICSI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic Regional Hospital Skive

Skive, 7800, Denmark

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Central Study Contacts

Peter Humaidan, Professor

CONTACT

78445760peter.humaidan@midt.rm.dk

Mette Jensen, Research assistant

CONTACT

78445718mejen8@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Consultant

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

April 25, 2023

Primary Completion

May 1, 2024

Study Completion

December 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)