SpermQT Prospective Observational Trial (SPOT)

Inherent Biosciences

Status: Enrolling

Conditions: Male Infertility

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05966883

SPOT001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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