Home semen testing for men starting to conceive
Randomized Controlled Trial of Home Semen Testing in Men Beginning Attempts to Conceive
This study is testing a home semen testing kit to see if it can help couples trying to conceive by making it easier to check for male infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05503862 on ClinicalTrials.gov |
What this trial studies
This study aims to improve early detection of male factor infertility by implementing a universal screening model using home semen testing. It focuses on assessing the feasibility and utility of this testing method for couples who are beginning their attempts to conceive. Participants will complete home semen tests to evaluate ease of use and identify any obstacles they may encounter. The goal is to reduce fertility-related anxiety and expedite evaluation and treatment for couples while minimizing unnecessary costs and health issues.
Who should consider this trial
Good fit: Ideal candidates are natal males over 18 years old, without prior children, who are interested in future fertility and have a current female partner.
Not a fit: Patients with a history of male infertility or those whose female partners have a history of infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of male infertility, reducing anxiety and improving treatment outcomes for couples trying to conceive.
How similar studies have performed: While the concept of home semen testing is relatively novel, similar approaches in fertility evaluation have shown promise in enhancing patient engagement and early detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Natal males over the age of 18 with no prior children who are interested in future fertility * Current female partner * Not attempting to conceive for more than 3 months * Willing to sign the Informed Consent Form * Able to read, understand, and complete patient questionnaires, pain texts, and medication diary. * Ownership or accessibility of a smart phone or electronic device that is compatible with the YoSperm® device Exclusion Criteria * Prior semen testing * History of male infertility, Klinefelter syndrome, undescended testis, or chemotherapy * Female partner with history of infertility * Female partner with irregular menstrual periods
Where this trial is running
Chicago, Illinois
- Northwestern University Department of Urology — Chicago, Illinois, United States (Recruiting)
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.