SpermQT Prospective Observational Trial (SPOT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Male Infertility

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • Male Fertility and Sexual Medicine Specialists
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Shady Grove Fertility
  • Connecticut
    • Orange, Connecticut, United States, 06477
      • Yale Medicine
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Boston IVF
  • Texas
    • Houston, Texas, United States, 77081
      • Inception Fertility, LLC
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Couples that are eligible for an IUI procedure and/or have been recommended to pursue IUI, and/or couples have recently completed an IUI cycle (no matter the outcome)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)	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)	18 months
Number of patients that have and have not achieved a live birth	Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)	18 months

Collaborators and Investigators

• Sponsor: Inherent Biosciences
• Collaborators: Yale University; University of Washington; Boston IVF; Brigham Young University; Shady Grove Fertility; Male Fertility and Sexual Medicine Specialists; Inception Fertility Research Institute, LLC
• Investigators: Principal Investigator: Kristin Brogaard, PhD, Inherent Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Epigenetics
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: SPOT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No