IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens
Recruiting now · Not applicable
Conditions studied: Infertility, Azoospermia
In brief
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).
Key facts
- Study ID
- NCT07074015
- Run by
- Brigham and Women's Hospital
- People needed
- 20
- Starts
- 2026-04-16
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
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.
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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