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Search / Trial NCT05966883

SpermQT Prospective Observational Trial

Launched by INHERENT BIOSCIENCES · Jul 20, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Epigenetics

ClinConnect Summary

The SpermQT Prospective Observational Trial is a study designed to evaluate a new test called the Epigenetic Sperm Quality Test (SpermQT). This test aims to help doctors understand the quality of a man's sperm and how it relates to the success of fertility treatments, specifically intrauterine insemination (IUI). If you or your partner are considering IUI or have recently completed the procedure, this trial might be of interest to you.

To participate, men should be under 45 years old and their female partners should be under 38. Additionally, the man's sperm count must be at least 10 million motile sperm per analysis. However, if either partner has a high body mass index (BMI of 40 or more), has taken testosterone therapy recently, or has certain medical conditions affecting fertility, they may not be eligible. If you join the study, you can expect to undergo the SpermQT test, which could provide valuable information about your sperm quality and help guide your fertility journey.

Gender

ALL

Eligibility criteria

  • 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

About Inherent Biosciences

Inherent Biosciences is a pioneering clinical trial sponsor dedicated to advancing the field of biotechnology through innovative research and development of diagnostic and therapeutic solutions. With a strong emphasis on precision medicine, the organization leverages cutting-edge technologies to enhance patient outcomes and drive scientific discovery. Inherent Biosciences collaborates with a network of healthcare professionals, research institutions, and regulatory bodies to ensure rigorous study design and compliance, ultimately aiming to accelerate the path from laboratory findings to clinical application. Committed to ethical standards and patient safety, Inherent Biosciences is at the forefront of transforming healthcare through evidence-based practices and novel therapeutic approaches.

Locations

Seattle, Washington, United States

Seattle, Washington, United States

Waltham, Massachusetts, United States

Greenwood Village, Colorado, United States

Orange, Connecticut, United States

San Diego, California, United States

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Kristin Brogaard, PhD

Principal Investigator

Inherent Biosciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported