An interventional study of Use of IntelliWell to identify and localize sperm for ICSI in Infertility and Azoospermia, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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).
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's planned enrollment of 20 is below the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Compared within Azoospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Female subject (with whom male subjects intends to conceive with surgically extracted sperm) cannot or will not provide her for study participation. She will undergo ICSI at BWH with BWH embryology.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Sperm detection rate by IntelliWell (sperm/min)
Time frame: Date of surgery and date of ICSI
Sperm retrieval success rate
Defined as at least one ICSI-grade sperm retrieved from IntelliWell
Time frame: Date of surgery and date of ICSI
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
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Nov 2027, 18 months after the start.
How these figures are worked out, and which studies are left out of them.
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