IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens
June 17, 2026 updated by: Martin Kathrins, M.D., Brigham and Women's Hospital
IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martin Kathrins, MD
- Phone Number: 617-732-6227
- Email: mkathrins@bwh.harvard.edu
Study Contact Backup
- Name: Siline Thai
- Phone Number: 617-525-8793
- Email: sthai1@bwh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Martin Kathrins, MD
- Phone Number: 617-732-6227
- Email: mkathrins@bwh.harvard.edu
-
Contact:
- Siline Thai
- Phone Number: 617-525-8793
- Email: sthai1@bwh.harvard.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
- Male subjects undergoing micro-surgical testicular sperm extraction surgery at Brigham and Women's Hospital.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IntelliWell Arm
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sperm detection rate by IntelliWell (sperm/min)
Time Frame: Date of surgery and date of ICSI
|
Date of surgery and date of ICSI
|
|
|
Sperm retrieval success rate
Time Frame: Date of surgery and date of ICSI
|
Defined as at least one ICSI-grade sperm retrieved from IntelliWell
|
Date of surgery and date of ICSI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total number of sperm detected in IntelliWell in fresh sample
Time Frame: Date of surgery
|
Date of surgery
|
|
Total number of sperm detected by IntelliWell in test-thaw samples
Time Frame: Day of surgery
|
Day of surgery
|
|
Total number of sperm detected by IntelliWell on day of ICSI
Time Frame: Date of ICSI
|
Date of ICSI
|
|
Time to first sperm detection and time to 10 sperm
Time Frame: Date of surgery and date of ICSI
|
Date of surgery and date of ICSI
|
|
Number of IntelliWell-identified sperm verified by embryology
Time Frame: Date of surgery and date of ICSI
|
Date of surgery and date of ICSI
|
|
Number of sperm retrieved and approved for ICSI
Time Frame: Date of ICSI
|
Date of ICSI
|
|
Total IntelliWell search time
Time Frame: Date of surgery and date of ICSI
|
Date of surgery and date of ICSI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bernie AM, Mata DA, Ramasamy R, Schlegel PN. Comparison of microdissection testicular sperm extraction, conventional testicular sperm extraction, and testicular sperm aspiration for nonobstructive azoospermia: a systematic review and meta-analysis. Fertil Steril. 2015 Nov;104(5):1099-103.e1-3. doi: 10.1016/j.fertnstert.2015.07.1136. Epub 2015 Aug 8.
- Kathrins M, Abhyankar N, Shoshany O, Liebermann J, Uhler M, Prins G, Niederberger C. Post-thaw recovery of rare or very low concentrations of cryopreserved human sperm. Fertil Steril. 2017 Jun;107(6):1300-1304. doi: 10.1016/j.fertnstert.2017.04.016. Epub 2017 May 5.
- Berger AJ, Raup V, Abou Ghayda R, Lanes A, Kathrins M. Inability to obtain sperm for fresh IVF cycles: analysis and incidence of outcomes using a database from the United States. Fertil Res Pract. 2020 Aug 11;6:14. doi: 10.1186/s40738-020-00082-3. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2026
Primary Completion (Estimated)
November 15, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
May 19, 2025
First Submitted That Met QC Criteria
July 17, 2025
First Posted (Actual)
July 20, 2025
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 17, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025p001209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.