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Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage

Primary Purpose

Infertility, Male, DNA Damage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intracytoplasmic sperm injection
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Failure to Conceive Due to Infertility of Male Partner, DNA Damage

Eligibility Criteria

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

Inclusion Criteria:

  • ≥18 years of age
  • be considered infertile (>1 year of unsuccessful attempts of conception
  • Any race
  • Male partner with persistent sperm DNA damage, DFI>=30%
  • candidates for intracytoplasmic sperm injection (ICSI)

Exclusion Criteria:

  • significant female factor infertility contributing to the couple's infertility
  • female partner older than 38 years
  • male or female patients with genetic abnormalities
  • patients unable or unwilling to give consent after properly informed
  • couples unsuitable for IVF/ICSI
  • male patients in whom testicular procedures were contraindicated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ejaculated sperm

    testicular extracted sperm

    Arm Description

    Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm

    Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm

    Outcomes

    Primary Outcome Measures

    Live birth rates

    Secondary Outcome Measures

    sperm DNA damage
    oocyte fertilization rates
    embryo cleavage rate
    blastocyst rate
    pregnancy rate
    Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound
    rate of spontaneous abortion
    birth defects

    Full Information

    First Posted
    January 27, 2014
    Last Updated
    February 6, 2014
    Sponsor
    Mount Sinai Hospital, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02058082
    Brief Title
    Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
    Official Title
    Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mount Sinai Hospital, Canada

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Male, DNA Damage
    Keywords
    Failure to Conceive Due to Infertility of Male Partner, DNA Damage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ejaculated sperm
    Arm Type
    Active Comparator
    Arm Description
    Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm
    Arm Title
    testicular extracted sperm
    Arm Type
    Active Comparator
    Arm Description
    Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm
    Intervention Type
    Procedure
    Intervention Name(s)
    Intracytoplasmic sperm injection
    Primary Outcome Measure Information:
    Title
    Live birth rates
    Time Frame
    Up to 1 year
    Secondary Outcome Measure Information:
    Title
    sperm DNA damage
    Time Frame
    Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
    Title
    oocyte fertilization rates
    Time Frame
    at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
    Title
    embryo cleavage rate
    Time Frame
    Day 3 post oocytes retrieval
    Title
    blastocyst rate
    Time Frame
    Day 5 post oocytes retrieval
    Title
    pregnancy rate
    Description
    Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound
    Time Frame
    6 to 8 week ultrasound
    Title
    rate of spontaneous abortion
    Time Frame
    after a clinical pregnancy has been established, up to 10 months after procedure
    Title
    birth defects
    Time Frame
    1-year following delivery

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥18 years of age be considered infertile (>1 year of unsuccessful attempts of conception Any race Male partner with persistent sperm DNA damage, DFI>=30% candidates for intracytoplasmic sperm injection (ICSI) Exclusion Criteria: significant female factor infertility contributing to the couple's infertility female partner older than 38 years male or female patients with genetic abnormalities patients unable or unwilling to give consent after properly informed couples unsuitable for IVF/ICSI male patients in whom testicular procedures were contraindicated
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kirk C. Lo, MD
    Organizational Affiliation
    MOUNT SINAI HOSPITAL
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage

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