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NCT Number: NCT07074015

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

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Key information

Conditions

Infertility Azoospermia Genital Diseases Genital Diseases, Male Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Sperm detection rate by IntelliWell (sperm/min)

    Time frame: Date of surgery and date of ICSI

  2. Sperm retrieval success rate

    Time frame: Date of surgery and date of ICSI

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

Secondary outcomes

  1. Total number of sperm detected in IntelliWell in fresh sample

    Time frame: Date of surgery

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

    Time frame: Day of surgery

  3. Total number of sperm detected by IntelliWell on day of ICSI

    Time frame: Date of ICSI

  4. Time to first sperm detection and time to 10 sperm

    Time frame: Date of surgery and date of ICSI

  5. Number of IntelliWell-identified sperm verified by embryology

    Time frame: Date of surgery and date of ICSI

  6. Number of sperm retrieved and approved for ICSI

    Time frame: Date of ICSI

  7. Total IntelliWell search time

    Time frame: Date of surgery and date of ICSI

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Kathrins, MD

CONTACT

[email protected]

617-732-6227

Siline Thai

CONTACT

[email protected]

617-525-8793

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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