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SPOT: SpermQT Prospective Observational Trial

Sponsor
Inherent Biosciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05966883
Collaborator
Yale University (Other), Boston IVF (Other), Shady Grove Fertility (Other), University of Washington (Other), Brigham Young University (Other), Male Fertility and Sexual Medicine Specialists (Other)
1,000
Enrollment
5
Locations
36
Anticipated Duration (Months)
200
Patients Per Site
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    SpermQT Prospective Observational Trial
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jan 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI) [6 months]

      Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)

    Secondary Outcome Measures

    1. Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF) [18 months]

      Number of patients that have and have not achieved pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent)

    2. Number of patients that have and have not achieved a live birth [18 months]

      Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome)

    • Male partner is under 45 years of age

    • Female partner is under 38 years of age

    • The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million

    Exclusion Criteria:

    • The female or male partner have a BMI equal to or greater than 40

    • The male partner has undergone male testosterone replacement therapy in the last 6 months

    • Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses

    • There are any known factors contributing to female factor infertility, such as but not limited to:

    • Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)

    • Multiple uterine fibroids 5cm or larger

    • Severe Asherman's Syndrome

    • Severe Mullerian anomaly

    • Lack of tubal patency in at least one fallopian tubes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Male Fertility and Sexual Medicine Specialists San Diego California United States 92120
    2 Shady Grove Fertility Greenwood Village Colorado United States 80111
    3 Yale Medicine Orange Connecticut United States 06477
    4 Boston IVF Waltham Massachusetts United States 02451
    5 University of Washington Seattle Washington United States 98105

    Sponsors and Collaborators

    • Inherent Biosciences
    • Yale University
    • Boston IVF
    • Shady Grove Fertility
    • University of Washington
    • Brigham Young University
    • Male Fertility and Sexual Medicine Specialists

    Investigators

    • Principal Investigator: Kristin Brogaard, PhD, Inherent Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inherent Biosciences
    ClinicalTrials.gov Identifier:
    NCT05966883
    Other Study ID Numbers:
    • SPOT001
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 3, 2023
    Last Verified:
    Aug 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
    Keywords provided by Inherent Biosciences
    Epigenetics
    Additional relevant MeSH terms:
    Infertility
    Infertility, Male

    Study Results

    No Results Posted as of Aug 3, 2023