Trials / Recruiting
RecruitingNCT07074015
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Use of IntelliWell to identify and localize sperm for ICSI | The experimental arm will have surgically extracted testicular sperm processed with IntelliWell. If identified and confirmed by embryology, cryopreservation of sperm will occur. On day of ICSI, thaw of testicular sperm will occur and be processed by IntelliWell for identification and localization for use in ICSI. |
Timeline
- Start date
- 2026-04-15
- Primary completion
- 2027-11-15
- Completion
- 2027-12-01
- First posted
- 2025-07-20
- Last updated
- 2026-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07074015. Inclusion in this directory is not an endorsement.