Clinical Trial

IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens

Recruiting
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Summary
This study will help determine whether an AI-assisted microwell platform (IntelliWell) can identify rare sperm cells in testicular samples found to not have sperm by conventional analysis. Instead of discarding testicular tissue which was found to be non-sperm bearing by conventional analysis the testicular tissue will be processed using IntelliWell and, if sperm is found and verified by embryologists, it may be used for intracytoplasmic sperm injection (ICSI).
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-16
Trial Details
NCT Number NCT07074015
Lead Sponsor Brigham and Women's Hospital
Conditions Infertility, Azoospermia
Enrollment 20 participants
Start Date 2026-04-16
Primary Completion 2027-11-15 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-22