SpermQT Prospective Observational Trial

Last updated: February 19, 2024
Sponsor: Inherent Biosciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypogonadism

Men's Health

Infertility

Treatment

N/A

Clinical Study ID

NCT05966883
SPOT001
  • Ages 18-45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subjects have been recommended to pursue IUI, or they have recently completed anIUI (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 equalto 10 million

Exclusion

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 6months
  • Either the female or male partner have a history of recurrent pregnancy loss, definedas 2 or more consecutive clinical/ultrasound pregnancy losses
  • There are any known factors contributing to female factor infertility, such as but notlimited 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

Study Design

Total Participants: 1000
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • Male Fertility and Sexual Medicine Specialists

    San Diego, California 92120
    United States

    Active - Recruiting

  • Shady Grove Fertility

    Greenwood Village, Colorado 80111
    United States

    Active - Recruiting

  • Yale Medicine

    Orange, Connecticut 06477
    United States

    Active - Recruiting

  • Boston IVF

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Inception Fertility, LLC

    Houston, Texas 77081
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98105
    United States

    Active - Recruiting

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