SpermQT Prospective Observational Trial

Recruiting

• Conditions: Male Infertility

• Registration Number: NCT05966883
• Lead Sponsor: Inherent Biosciences

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.

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 Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Number of patients that have and have not achieved a live birth	18 months	Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)
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 pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent)

Trial Locations

Locations (6)

Male Fertility and Sexual Medicine Specialists; 🇺🇸 San Diego, California, United States

Inception Fertility, LLC; 🇺🇸 Houston, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Yale Medicine; 🇺🇸 Orange, Connecticut, United States

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States

Shady Grove Fertility; 🇺🇸 Greenwood Village, Colorado, United States