SpermQT Prospective Observational Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Male Infertility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No