Evaluating a new test for male sperm quality in infertility treatments
SpermQT Prospective Observational Trial
Inherent Biosciences · NCT05966883
This study is testing a new sperm quality test to see if it can help men undergoing infertility treatments achieve pregnancy and live births.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Inherent Biosciences (industry) |
| Locations | 6 sites (San Diego, California and 5 other locations) |
| Trial ID | NCT05966883 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Epigenetic Sperm Quality Test (SpermQT) by analyzing semen samples from men undergoing infertility treatments. Participants will have their SpermQT scores assessed, and the study will track the success of fertility treatments in achieving pregnancy and live births. Both physicians and patients will remain unaware of the SpermQT results to ensure unbiased outcomes. The study focuses on men recommended for intrauterine insemination (IUI) or those who have recently completed an IUI.
Who should consider this trial
Good fit: Ideal candidates include men under 45 years old whose female partners are under 38 and who have a sufficient sperm count for IUI.
Not a fit: Patients with a BMI of 40 or higher, a history of recurrent pregnancy loss, or significant female factor infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for assessing sperm quality, potentially improving the success rates of infertility treatments.
How similar studies have performed: While the concept of assessing sperm quality is established, the specific use of the SpermQT test in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California and 5 other locations
- Male Fertility and Sexual Medicine Specialists — San Diego, California, United States (RECRUITING)
- Shady Grove Fertility — Greenwood Village, Colorado, United States (RECRUITING)
- Yale Medicine — Orange, Connecticut, United States (RECRUITING)
- Boston IVF — Waltham, Massachusetts, United States (RECRUITING)
- Inception Fertility, LLC — Houston, Texas, United States (RECRUITING)
- University of Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Kristin Brogaard, PhD — Inherent Biosciences
- Study coordinator: Kristin Brogaard, PhD
- Email: kristin@inherentbio.com
- Phone: 760-815-8706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Male Infertility, Epigenetics