Post-thaw recovery of rare or very low concentrations of cryopreserved human sperm.
Martin Kathrins, Nikita Abhyankar, Ohad Shoshany...
https://pubmed.ncbi.nlm.nih.gov/28483505Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID07074015
IntelliWell: An AI-Assisted Microwell Platform for Label-Free Localization of Ultra-Rare Sperm in Non-Obstructive Azoospermia Micro-TESE Specimens
Led by Brigham and Women's Hospital · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether an AI-assisted microwell platform called IntelliWell can find rare sperm cells in testicular samples that conventional methods do not detect. The study focuses on men with non-obstructive azoospermia, a condition causing infertility due to lack of sperm in semen. This platform aims to improve sperm detection in surgical specimens that would otherwise be discarded after standard analysis shows no usable sperm. Participants will undergo microsurgical testicular sperm extraction (micro-TESE) surgery, and the extracted tissue will be processed using the IntelliWell device. If IntelliWell identifies sperm and embryologists confirm their presence, the sperm will be cryopreserved. On the day of intracytoplasmic sperm injection (ICSI), the stored sperm will be thawed and analyzed again with IntelliWell for use in the ICSI procedure. During the study, researchers will measure the sperm detection rate and success of sperm retrieval by IntelliWell at surgery and ICSI dates. They will also track the number of sperm found in fresh and thawed samples, the time to detect sperm, and confirmation by embryologists. The study includes safety monitoring and follow-up during sperm processing and ICSI. Participation involves surgery, tissue processing, sperm analysis, and clinical procedures related to infertility treatment.
CONDITIONS
Brief Title
IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male subjects with infertility diagnosed with non-obstructive azoospermia based on two semen analyses, physical exam, and hormone testing
- Undergoing micro-surgical testicular sperm extraction surgery at Brigham and Women's Hospital
- Surgically extracted sperm samples found to have no clinically usable sperm after standard processing, which would otherwise be discarded
You will not qualify if you...
- Female partner of the male subject cannot or will not provide informed consent for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo micro-surgical testicular sperm extraction surgery, during which sperm samples are processed with IntelliWell to identify and localize sperm for cryopreservation.
1 visit (surgery day)
Treatment
Duration - Day of ICSI
On the day of ICSI, thawed testicular sperm are processed by IntelliWell for identification and localization to be used in ICSI treatment.
1 visit (ICSI day)
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
M
Martin Kathrins, MD
S
Siline Thai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Comparison of microdissection testicular sperm extraction, conventional testicular sperm extraction, and testicular sperm aspiration for nonobstructive azoospermia: a systematic review and meta-analysis.
Aaron M Bernie, Douglas A Mata, Ranjith Ramasamy...
https://pubmed.ncbi.nlm.nih.gov/26263080Inability to obtain sperm for fresh IVF cycles: analysis and incidence of outcomes using a database from the United States.
Alexandra Joice Berger, Valary Raup, Ramy Abou Ghayda...
https://pubmed.ncbi.nlm.nih.gov/32793376