SpermQT Prospective Observational Trial

Male Infertility Clinical Trial

— SPOT  

Official title:

SpermQT Prospective Observational Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966883
• Other study ID #: SPOT001
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Inherent Biosciences
• Contact: Kristin Brogaard, PhD
• Phone: 760-815-8706
• Email: kristin[@]inherentbio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years to 45 Years

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Locations

Country	Name	City	State
United States	Shady Grove Fertility	Greenwood Village	Colorado
United States	Inception Fertility, LLC	Houston	Texas
United States	Yale Medicine	Orange	Connecticut
United States	Male Fertility and Sexual Medicine Specialists	San Diego	California
United States	University of Washington	Seattle	Washington
United States	Boston IVF	Waltham	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Inherent Biosciences	Boston IVF, Brigham Young University, Inception Fertility, LLC, Male Fertility and Sexual Medicine Specialists, Shady Grove Fertility, University of Washington, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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