IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sperm detection rate by IntelliWell (sperm/min)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
IntelliWell Arm
干预措施: Use of IntelliWell to identify and localize sperm for ICSI (Device)
结局指标
主要结局
Sperm detection rate by IntelliWell (sperm/min)
时间窗: Date of surgery and date of ICSI
Sperm retrieval success rate
时间窗: Date of surgery and date of ICSI
Defined as at least one ICSI-grade sperm retrieved from IntelliWell
次要结局
- Total number of sperm detected in IntelliWell in fresh sample(Date of surgery)
- Total number of sperm detected by IntelliWell in test-thaw samples(Day of surgery)
- Total number of sperm detected by IntelliWell on day of ICSI(Date of ICSI)
- Time to first sperm detection and time to 10 sperm(Date of surgery and date of ICSI)
- Number of IntelliWell-identified sperm verified by embryology(Date of surgery and date of ICSI)
- Number of sperm retrieved and approved for ICSI(Date of ICSI)
- Total IntelliWell search time(Date of surgery and date of ICSI)
研究者
Martin Kathrins, M.D.
Principal Investigator
Brigham and Women's Hospital