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SpermQT Prospective Observational Trial

SpermQT Prospective Observational Trial

Recruiting
18-45 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Male Infertility

NCT05966883

Inherent Biosciences

27 January 2024

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