IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of IntelliWell to identify and localize sperm for ICSI.
- Who it may be relevant to
- Registry conditions: Infertility, Azoospermia. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens
Overview
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).
Interventions
- Device 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.
Primary outcome measures
- Sperm detection rate by IntelliWell (sperm/min) [Time frame: Date of surgery and date of ICSI]
- Sperm retrieval success rate [Time frame: Date of surgery and date of ICSI]
Secondary outcome measures (7)
- Total number of sperm detected in IntelliWell in fresh sample [Time frame: Date of surgery]
- Total number of sperm detected by IntelliWell in test-thaw samples [Time frame: Day of surgery]
- Total number of sperm detected by IntelliWell on day of ICSI [Time frame: Date of ICSI]
- Time to first sperm detection and time to 10 sperm [Time frame: Date of surgery and date of ICSI]
- Number of IntelliWell-identified sperm verified by embryology [Time frame: Date of surgery and date of ICSI]
- Number of sperm retrieved and approved for ICSI [Time frame: Date of ICSI]
- Total IntelliWell search time [Time frame: Date of surgery and date of ICSI]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Publications
- 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
Identifiers
NCT: NCT07074015 · 2025p001209