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).
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.
None
Single group
Use of IntelliWell to identify and localize sperm for ICSI
DeviceThe 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.
Sperm detection rate by IntelliWell (sperm/min)
Sperm retrieval success rate
Defined as at least one ICSI-grade sperm retrieved from IntelliWell
Total number of sperm detected in IntelliWell in fresh sample
Total number of sperm detected by IntelliWell in test-thaw samples
Total number of sperm detected by IntelliWell on day of ICSI
Time to first sperm detection and time to 10 sperm
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