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DNA Fragmentation - Effect on Pregnancy Rate

Primary Purpose

Infertility, Male

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Punalpin
Placebo
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male fertility patients with increased amount of DNA fragmentation in their spermatozoa

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Punalpin

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sperm DNA fragmentation
    Reduction in DNA fragmentation

    Secondary Outcome Measures

    Full Information

    First Posted
    October 15, 2019
    Last Updated
    May 25, 2022
    Sponsor
    Odense University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05397314
    Brief Title
    DNA Fragmentation - Effect on Pregnancy Rate
    Official Title
    DNA Fragmentation - Effect on Pregnancy Rate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    January 9, 2021 (Actual)
    Study Completion Date
    April 9, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Odense University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Male

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Punalpin
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Punalpin
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Sperm DNA fragmentation
    Description
    Reduction in DNA fragmentation
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male fertility patients with increased amount of DNA fragmentation in their spermatozoa Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    DNA Fragmentation - Effect on Pregnancy Rate

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