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

NCT07074015 | Recruiting

• 1 other identifier: 2025p001209
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Infertility; Azoospermia

Keywords

infertility; azoospermia; micro-TESE

Outcome Measures

Primary Outcomes (2)

• Sperm detection rate by IntelliWell (sperm/min)

  Date of surgery and date of ICSI

• Sperm retrieval success rate

  Defined as at least one ICSI-grade sperm retrieved from IntelliWell

  Date of surgery and date of ICSI

Secondary Outcomes (7)

• Total number of sperm detected in IntelliWell in fresh sample

  Date of surgery

• Total number of sperm detected by IntelliWell in test-thaw samples

  Day of surgery

• Total number of sperm detected by IntelliWell on day of ICSI

  Date of ICSI

• Time to first sperm detection and time to 10 sperm

  Date of surgery and date of ICSI

• Number of IntelliWell-identified sperm verified by embryology

  Date of surgery and date of ICSI

Study Arms (1)

IntelliWell Arm

EXPERIMENTAL

Device: Use of IntelliWell to identify and localize sperm for ICSI

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.

IntelliWell Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 28483505 BACKGROUND

• 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.

  PMID: 26263080 BACKGROUND

• 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.

  PMID: 32793376 BACKGROUND

MeSH Terms

Conditions

Infertility; Azoospermia

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Infertility, Male; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Central Study Contacts

Martin Kathrins, MD

CONTACT

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

Siline Thai

CONTACT

617-525-8793; sthai1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: July 20, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)