NCT07074015 IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens
| NCT ID | NCT07074015 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-04-15 with a primary completion date of 2027-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07074015 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07074015 currently recruiting?
Yes, NCT07074015 is actively recruiting participants. Contact the research team at mkathrins@bwh.harvard.edu for enrollment information.
Where is the NCT07074015 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07074015 clinical trial?
NCT07074015 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 20 participants.