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

Not Applicable

Not yet recruiting

• Conditions: Infertility; Azoospermia

• Registration Number: NCT07074015
• Lead Sponsor: Brigham and Women's Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-19
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sperm detection rate by IntelliWell (sperm/min)	Date of surgery and date of ICSI
Sperm retrieval success rate	Date of surgery and date of ICSI	Defined as at least one ICSI-grade sperm retrieved from IntelliWell

Secondary Outcome Measures

Name	Time	Method
Total number of sperm detected in IntelliWell in fresh sample	Date of surgery
Total number of sperm detected by IntelliWell in test-thaw samples	Day of surgery
Total number of sperm detected by IntelliWell on day of ICSI	Date of ICSI
Time to first sperm detection and time to 10 sperm	Date of surgery and date of ICSI
Number of IntelliWell-identified sperm verified by embryology	Date of surgery and date of ICSI
Number of sperm retrieved and approved for ICSI	Date of ICSI
Total IntelliWell search time	Date of surgery and date of ICSI