Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07074015

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

Led by Brigham and Women's Hospital · Updated on 2026-04-15

20

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male subjects with infertility diagnosed with clinical non-obstructive azoospermia 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 samples that show no clinically usable sperm after standard manual processing and would otherwise be discarded
Not Eligible

You will not qualify if you...

  • Female partner who cannot or will not provide informed consent for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

M

Martin Kathrins, MD

CONTACT

S

Siline Thai

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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