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TESA vs Zymot: Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)

Sponsor
Clinique Ovo (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05866484
Collaborator
(none)
280
Enrollment
1
Location
7.7
Anticipated Duration (Months)
36.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate.

The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    280 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better
    Actual Study Start Date :
    May 10, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    TESA-ICSI

    Compare ICSI outcomes with high Sperm DNA fragmentation undergoing TESA (testicular sperm extraction)
    Zymot-ICSI

    Compare ICSI outcomes with high Sperm DNA fragmentation using microfluidic sperm separation device (Zymot)

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Pregnancy Rate [approximately 8 weeks]

      Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation

    Secondary Outcome Measures

    1. Number of utilizable blastocysts obtained [Approximately 20 days]

      Compare the number of utilizable embryos obtained in couples using TESA-ICSI vs Zymot-ICSI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI
    Exclusion Criteria:

    • Spouse with advanced maternal age (> 40 years)

    • Egg donation cycle

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Ovo Montreal Quebec Canada H4P 2S4

    Sponsors and Collaborators

    • Clinique Ovo

    Investigators

    • Principal Investigator: Armand Zini, MD, Clinique Ovo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Ovo
    ClinicalTrials.gov Identifier:
    NCT05866484
    Other Study ID Numbers:
    • 3277
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Azoospermia
    Infertility, Male

    Study Results

    No Results Posted as of May 19, 2023