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

IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens

Who can join

Ages 18 and older · Men

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.

About the study

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).

What is being tested

• Use of IntelliWell to identify and localize sperm for ICSI (device)

Sponsor: Brigham and Women's Hospital · Participants: 20 · Started: Apr 16, 2026

Contact the study team

• Martin Kathrins, MD · Phone: 617-732-6227
• Siline Thai · Phone: 617-525-8793

Official record on ClinicalTrials.gov — NCT07074015

Locations in the U.S.

Conditions

• Infertility

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.