Status:
RECRUITING
SpermQT Prospective Observational Trial
Lead Sponsor:
Inherent Biosciences
Collaborating Sponsors:
Yale University
Boston IVF
Conditions:
Male Infertility
Eligibility:
All Genders
18-45 years
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 bir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05966883
Start Date
January 1 2023
End Date
January 1 2026
Last Update
February 21 2024
Active Locations (6)
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1
Male Fertility and Sexual Medicine Specialists
San Diego, California, United States, 92120
2
Shady Grove Fertility
Greenwood Village, Colorado, United States, 80111
3
Yale Medicine
Orange, Connecticut, United States, 06477
4
Boston IVF
Waltham, Massachusetts, United States, 02451