Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

NCT ID: NCT05846256

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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Conditions

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Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infertile male

Men with unexplained infertility

Sperm DNA Fragmentation

Intervention Type OTHER

Sperm DNA Fragmentation analysis.

Donors (control)

Fertile sperm donors

Sperm DNA Fragmentation

Intervention Type OTHER

Sperm DNA Fragmentation analysis.

Interventions

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Sperm DNA Fragmentation

Sperm DNA Fragmentation analysis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- ICSI
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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ExamenLab Ltd

UNKNOWN

Sponsor Role collaborator

Peter Humaidan

OTHER

Sponsor Role lead

Responsible Party

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Peter Humaidan

Professor, Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fertility Clinic Regional Hospital Skive

Skive, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Peter Humaidan, Professor

Role: CONTACT

Mette Jensen, Research assistant

Role: CONTACT

Facility Contacts

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Birgit Alsbjerg, M.D.

Role: primary

+45 78 44 57 60

Alice Mikkelsen

Role: backup

Other Identifiers

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Doublestrand DNA Fragmentation

Identifier Type: -

Identifier Source: org_study_id

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