RecruitingNot Applicable

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

United States20 participantsStarted 2026-04-15

Plain-language 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).

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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).
✓. Male subjects undergoing micro-surgical testicular sperm extraction surgery at Brigham and Women's Hospital.
✓. 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.

What they're measuring

Sperm detection rate by IntelliWell (sperm/min)

Timeframe: Date of surgery and date of ICSI

Sperm retrieval success rate

Timeframe: Date of surgery and date of ICSI

Trial details

NCT IDNCT07074015

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-15

Contact for this trial

Martin Kathrins, MD

617-732-6227 mkathrins@bwh.harvard.edu

View on ClinicalTrials.gov More Infertility trials