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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new technology called IntelliWell, which uses artificial intelligence (AI) to help find very rare sperm cells in testicular tissue samples from men with a type of infertility called non-obstructive azoospermia—meaning no sperm is found in their semen. Normally, if no sperm is found using standard methods, the tissue is discarded. But with IntelliWell, the tissue is carefully rechecked using this AI platform to see if any sperm can be found. If sperm are found and confirmed by experts, they may be used in a fertility treatment called intracytoplasmic sperm injection (ICSI), where a single sperm is injected directly into an egg to help with fertilization.

Men who might be eligible for this study are those diagnosed with non-obstructive azoospermia and who are already having surgery to try to retrieve sperm from their testicles at Brigham and Women’s Hospital. Specifically, the study focuses on men whose testicular tissue did not show any usable sperm with the usual testing methods and would normally be considered unsuccessful. Participants can expect that instead of discarding this tissue, it will be analyzed using the IntelliWell system to try to find rare sperm that could help with fertility treatments. It’s important to note that the female partner must agree to participate if she will be involved in using the sperm for fertilization. The study is not yet enrolling participants but aims to improve options for men facing this challenging diagnosis.

Gender

MALE

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.