IntelliWell: AI imaging to find ultra-rare sperm in testicular tissue
Official title: IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens
Run by Brigham and Women's Hospital · NCT07074015 · Data updated 2026-11-12
This will try an AI-assisted imaging platform to find rare sperm in testicular samples from men with non-obstructive azoospermia when standard processing finds no sperm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | April 16, 2026 |
| Main results expected | November 15, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07074015 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with clinical non-obstructive azoospermia undergoing micro‑TESE at Brigham and Women's whose surgically extracted tissue contains no clinically usable sperm after standard processing are ideal candidates.
✕Probably not a fit
Patients whose samples already contain sufficient sperm by standard processing, patients with obstructive azoospermia not meeting inclusion criteria, or couples where the partner does not consent to ICSI are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Men with non-obstructive azoospermia who undergo micro‑TESE at Brigham and Women's Hospital and whose extracted tissue has no sperm on standard manual processing will have that tissue processed with the IntelliWell microwell platform. IntelliWell uses AI-assisted imaging to scan and localize candidate sperm cells within processed testicular samples. Embryologists will review and verify any candidate sperm identified by the platform, and verified sperm may be used for intracytoplasmic sperm injection (ICSI). This is a single-center, interventional use of a novel imaging/selection tool applied to samples that would otherwise be discarded.
Why it matters
Potential benefit: If successful, IntelliWell could enable discovery of usable sperm in samples previously deemed unusable, increasing chances for men with non-obstructive azoospermia to have sperm available for ICSI.
How similar studies have gone: AI tools have been applied to semen analysis and imaging in related areas, but applying an AI‑assisted microwell platform to locate ultra‑rare testicular sperm is largely novel with limited prior clinical evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male subjects presenting to Brigham and Women's or Faulkner urology clinic with infertility with clinical non-obstructive azoospermia (clinical diagnosis based on two semen analyses, physical examination, and hormonal testing). 2. Male subjects undergoing micro-surgical testicular sperm extraction surgery at Brigham and Women's Hospital. 3. Surgically extracted sperm which are not found to have clinically usable quantities of sperm after standard of care manual processing for which samples would otherwise be discarded and the procedure deemed unsuccessful. Exclusion Criteria: 1\. Female subject (with whom male subjects intends to conceive with surgically extracted sperm) cannot or will not provide her informed consent for study participation. She will undergo ICSI at BWH with BWH embryology.
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Martin Kathrins, MD
- Email: mkathrins@bwh.harvard.edu
- Phone: 617-732-6227
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.