Clincosm LogoSign in Get a demo

FERTIMACS: Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip

Sponsor
IVI Sevilla (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04061486
Collaborator
IVI Madrid (Other)
80
Enrollment
1
Location
26.8
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.

Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip
    Actual Study Start Date :
    Aug 8, 2019
    Actual Primary Completion Date :
    May 15, 2021
    Anticipated Study Completion Date :
    Oct 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Experimental arm

    One half of the oocyte cohort is microinjected with sperm selected by the Fertile technique, while the other half of the patient's oocyte cohort is microinjected with sperm selected by the MACS technique.

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate [Mar 2019 - Oct 2021]

      Total of positive pregnancies / total of patients with embryo transfer

    Secondary Outcome Measures

    1. Fertilization rate [Mar 2019 - Oct 2021]

      Total of oocyte fertilized / total of oocyte injected

    2. Implantation rate [Mar 2019 - Oct 2021]

      Total of implanted embryos / total of transferred embryos

    3. Blastocyst rate [Mar 2019 - Oct 2021]

      Total of bastocyst / total of oocyte fertilized

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Oocyte recipient patients
    Exclusion Criteria:

    • Sperm concentration < 5 Mill/ml

    • Percentage of motile sperm < 15%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVI RMA Seville Seville Spain 41011

    Sponsors and Collaborators

    • IVI Sevilla
    • IVI Madrid

    Investigators

    • Principal Investigator: Cristina González Ravina, PhD, IVI RMA Seville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IVI Sevilla
    ClinicalTrials.gov Identifier:
    NCT04061486
    Other Study ID Numbers:
    • 1904-SEV-050-CR
    First Posted:
    Aug 19, 2019
    Last Update Posted:
    Jun 30, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by IVI Sevilla
    MACS
    DNA fragmentation
    Sperm selection
    Additional relevant MeSH terms:
    Infertility
    Infertility, Male

    Study Results

    No Results Posted as of Jun 30, 2021