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

Официальное название

IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens

Обзор

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).

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

• Total number of sperm detected in IntelliWell in fresh sample [Срок оценки: Date of surgery]
• Total number of sperm detected by IntelliWell in test-thaw samples [Срок оценки: Day of surgery]
• Total number of sperm detected by IntelliWell on day of ICSI [Срок оценки: Date of ICSI]
• Time to first sperm detection and time to 10 sperm [Срок оценки: Date of surgery and date of ICSI]
• Number of IntelliWell-identified sperm verified by embryology [Срок оценки: Date of surgery and date of ICSI]
• Number of sperm retrieved and approved for ICSI [Срок оценки: Date of ICSI]
• Total IntelliWell search time [Срок оценки: Date of surgery and date of ICSI]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Публикации

• Kathrins M, Abhyankar N, Shoshany O, Liebermann J, Uhler M, Prins G, Niederberger C. Post-thaw recovery of rare or very low concentrations of cryopreserved human sperm. Fertil Steril. 2017 Jun;107(6):1300-1304. doi: 10.1016/j.fertnstert.2017.04.016. Epub 2017 May 5. PMID 28483505
• Bernie AM, Mata DA, Ramasamy R, Schlegel PN. Comparison of microdissection testicular sperm extraction, conventional testicular sperm extraction, and testicular sperm aspiration for nonobstructive azoospermia: a systematic review and meta-analysis. Fertil Steril. 2015 Nov;104(5):1099-103.e1-3. doi: 10.1016/j.fertnstert.2015.07.1136. Epub 2015 Aug 8. PMID 26263080
• Berger AJ, Raup V, Abou Ghayda R, Lanes A, Kathrins M. Inability to obtain sperm for fresh IVF cycles: analysis and incidence of outcomes using a database from the United States. Fertil Res Pract. 2020 Aug 11;6:14. doi: 10.1186/s40738-020-00082-3. eCollection 2020. PMID 32793376

Идентификаторы

NCT: NCT07074015 · 2025p001209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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