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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07074015
Status
Recruiting
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Conditions

  • Azoospermia
  • Infertility

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Use of IntelliWell to identify and localize sperm for ICSI — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
Nov 15, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IntelliWell Arm

Primary Outcome Measure

Sperm detection rate by IntelliWell (sperm/min) [ Time Frame: Date of surgery and date of ICSI ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Martin Kathrins, MD
[email protected]
617-732-6227
Siline Thai
[email protected]
617-525-8793

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By research site
Brigham and Women's Hospital· Boston, MA

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