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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-12-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Infertility Azoospermia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IntelliWell Arm

Group Type EXPERIMENTAL

Use of IntelliWell to identify and localize sperm for ICSI

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No