Male Infertility
Conditions
Keywords
Epigenetics
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.
Interventions
None listed
Sponsors
Inherent Biosciences
Yale University
Boston IVF
Shady Grove Fertility
University of Washington
Brigham Young University
Male Fertility and Sexual Medicine Specialists
Inception Fertility Research Institute, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI) | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF) | 18 months | 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) |
| Number of patients that have and have not achieved a live birth | 18 months | Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKristin Brogaard, PhD
Inherent Biosciences
Outcome results
None listed