Recruiting

IntelliWell

Sponsor:

Brigham and Women's Hospital

Code:

NCT07074015

Conditions

Infertility

Azoospermia

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of IntelliWell to identify and localize sperm for ICSI

Study Details

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

Study ID

NCT07074015

Start date

Apr 16, 2026

Status verified date

Jun, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IntelliWell Arm

Interventions

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.

Primary outcome measure

  • Sperm detection rate by IntelliWell (sperm/min) [ Time Frame: Date of surgery and date of ICSI ]
  • Sperm retrieval success rate [ Time Frame: Date of surgery and date of ICSI ]

Central Contacts and Locations

Central contacts

Martin Kathrins, MD

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

Siline Thai

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

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Martin Kathrins, MD

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

Siline Thai

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

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • infertility
  • azoospermia
  • micro-TESE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-22.