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ReproDNA: DNA Damage and Subfertility in Males - Impact on ART Outcome

Sponsor
Regionshospitalet Viborg, Skive (Other)
Overall Status
Recruiting
CT.gov ID
NCT04160208
Collaborator
(none)
1,350
Enrollment
1
Location
37
Anticipated Duration (Months)
36.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome
    Actual Study Start Date :
    Oct 1, 2019
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    IUI - Insemination

    Males of couples undergoing their first IUI treatment
    IVF - In vitro fertilisation

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of particpants achieving live birth [week 23-42 of pregnancy]

      Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.

    Secondary Outcome Measures

    1. Number of participants with clinical pregnancy [week 7-8 of pregnancy]

      Measurement of heart beat by ultrasound scan

    2. Number of participants with biochemical pregnancy [Day 14-17 of pregnancy]

      Increase in serum hCG levels

    3. Cumulative live birth rate [9-24 months after inclusion]

      Live births originating from one controlled stimulation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • First cycle treatment
    Exclusion Criteria:
    • TESA/PESA, more than one cycle

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fertility Clinic, Skive Regional Hospital Skive Denmark

    Sponsors and Collaborators

    • Regionshospitalet Viborg, Skive

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
    ClinicalTrials.gov Identifier:
    NCT04160208
    Other Study ID Numbers:
    • DFI2019Skivecohort
    First Posted:
    Nov 12, 2019
    Last Update Posted:
    Mar 11, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Keywords provided by Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
    male infertility
    DNA fragmentation Index
    DFI
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Mar 11, 2022