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

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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

NCT07074015•Brigham and Women's Hospital

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Key Dates

Start Date

February 1, 2026

Primary Completion Date

February 15, 2027

Completion Date

December 1, 2027

Last Updated

November 19, 2025

Enrollment

ESTIMATED participants

Conditions

InfertilityAzoospermia

Interventions

Use of IntelliWell to identify and localize sperm for ICSI

DEVICE

Contacts

Martin Kathrins, MD

CONTACT

617-732-6227 mkathrins@bwh.harvard.edu

Immune Cell Populations in the Endometrium

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Infertility, FemaleRecurrent Miscarriage+1 more

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RECRUITINGPHASE2

Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

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InfertilityInsemination

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Immune Cell Populations in the Endometrium

Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

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Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate

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