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NCT07074015NARecruiting

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

Brigham and Women's Hospital

Start Date

4/16/2026

Completion Date

12/1/2027

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Use of IntelliWell to identify and localize sperm for ICSI

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Conditions

InfertilityAzoospermia

Locations

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States