DNA Damage and Subfertility in Males - Impact on ART Outcome

NCT ID: NCT04160208

Last Updated: 2023-07-06

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

1350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-11-01

Brief Summary

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A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IUI - Insemination

Males of couples undergoing their first IUI treatment

No interventions assigned to this group

IVF - In vitro fertilisation

Males of couples undergoing their first IVF treatment. Including males of couples who have had previous IUI treatments.

No interventions assigned to this group

ICSI - Micro Insemination

Males of couples undergoing their first ICSI treatment. Including males of couples who have had previous IUI treatments.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* First cycle treatment

Exclusion Criteria

* TESA/PESA, more than one cycle
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role lead

Responsible Party

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Peter Humaidan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fertility Clinic, Skive Regional Hospital

Skive, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Peter Humaidan, DMSc

Role: primary

+4578445760

Other Identifiers

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DFI2019Skivecohort

Identifier Type: -

Identifier Source: org_study_id

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