Clinical trial NCT05966883: SpermQT Prospective Observational Trial
Official title: SpermQT Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Male Infertility
Keywords: Epigenetics
Lead sponsor: Inherent Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Yale University
name: Boston IVF
name: Shady Grove Fertility
name: University of Washington
name: Brigham Young University
name: Male Fertility and Sexual Medicine Specialists
name: Inception Fertility Research Institute, LLC
First posted: 2023-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples that are eligible for an IUI procedure and/or have been recommended to pursue IUI, and/or couples have recently completed an IUI cycle (no matter the outcome)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)
timeFrame: 18 months
measure: Number of patients that have and have not achieved a live birth
timeFrame: 18 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Male Fertility and Sexual Medicine Specialists
state: California
city: Greenwood Village
country: United States
facility: Shady Grove Fertility
state: Colorado
city: Orange
country: United States
facility: Yale Medicine
state: Connecticut
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
city: Houston
country: United States
facility: Inception Fertility, LLC
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Inherent Biosciences
name: Kristin Brogaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: