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

Not Applicable
Not yet recruiting
Conditions
Infertility
Azoospermia
Registration Number
NCT07074015
Lead Sponsor
Brigham and Women's Hospital
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Male
Target Recruitment
20
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Sperm detection rate by IntelliWell (sperm/min)Date of surgery and date of ICSI
Sperm retrieval success rateDate of surgery and date of ICSI

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

Secondary Outcome Measures
NameTimeMethod
Total number of sperm detected in IntelliWell in fresh sampleDate of surgery
Total number of sperm detected by IntelliWell in test-thaw samplesDay of surgery
Total number of sperm detected by IntelliWell on day of ICSIDate of ICSI
Time to first sperm detection and time to 10 spermDate of surgery and date of ICSI
Number of IntelliWell-identified sperm verified by embryologyDate of surgery and date of ICSI
Number of sperm retrieved and approved for ICSIDate of ICSI
Total IntelliWell search timeDate of surgery and date of ICSI

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