SpermQT Prospective Observational Trial

NCT05966883 | Active Not Recruiting

• 1 other identifier: SPOT001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Male Infertility

Keywords

Epigenetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 a live birth

  18 months

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inherent Biosciences: lead
• Yale University: collaborator
• Boston IVF: collaborator
• Shady Grove Fertility: collaborator
• University of Washington: collaborator
• Brigham Young University: collaborator
• Male Fertility and Sexual Medicine Specialists: collaborator
• Inception Fertility Research Institute, LLC: collaborator

Study Sites (6)

Male Fertility and Sexual Medicine Specialists

San Diego, California, 92120, United States

Location

Shady Grove Fertility

Greenwood Village, Colorado, 80111, United States

Location

Yale Medicine

Orange, Connecticut, 06477, United States

Location

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Inception Fertility, LLC

Houston, Texas, 77081, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Semen sample

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Kristin Brogaard, PhD

  Inherent Biosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: August 1, 2023
• Study Start: January 1, 2023
• Primary Completion: April 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)