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ISO 27001 CertifiedActively Recruiting
Led by Brigham and Women's Hospital · Updated on 2026-06-22
20
Participants Needed
1
Research Sites
2 weeks
Total Duration
This research aims to evaluate whether an AI-assisted microwell platform called IntelliWell can detect very rare sperm cells in testicular samples that appear to have no sperm using conventional methods. The study focuses on men with infertility caused by non-obstructive azoospermia undergoing micro-surgical testicular sperm extraction. The goal is to find sperm that would otherwise be missed and discarded, potentially improving use in fertility treatments. Participants will have testicular tissue surgically extracted and processed with the IntelliWell device. If IntelliWell identifies sperm, embryologists will verify their presence. Verified sperm may then be cryopreserved and later thawed for use in intracytoplasmic sperm injection ICSI procedures. The study involves analysis both at the time of surgery and at the time of ICSI. During the study, researchers will measure the sperm detection rate by IntelliWell, success rates of sperm retrieval, total sperm detected in fresh and thawed samples, and time taken to find sperm. Embryology verification and approval for ICSI use will also be tracked. Participants are monitored from surgery through ICSI, with detailed assessments to understand the potential of this AI-assisted identification method.
CONDITIONS
IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Specimens
M
Martin Kathrins, MD
S
Siline Thai
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Brigham and Women's Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | AI-Assisted Sperm Identification (IntelliWell) | Standard Manual Sperm Identification |
|---|---|---|
| What it is | An artificial intelligence-assisted imaging platform developed to identify and localize ultra-rare testicular sperm in surgical specimens, specifically for men with non-obstructive azoospermia where standard methods have failed. | Manual microscopic examination and processing of surgically extracted testicular tissue to search for sperm, currently the standard method after micro-surgical extraction in non-obstructive azoospermia. |
| Role in the study | Used as the investigational device in cases where no sperm are found by standard manual methods, prior to sample discard. | Represents the routine clinical practice against which new methods are evaluated, and is the initial approach in clinical settings. |
| Primary use | To improve detection of very low concentrations of sperm in testicular tissue for use in intracytoplasmic sperm injection (ICSI) among men who otherwise would not have sperm available. | To manually search for sperm in testicular tissue for spermatogenic failure cases as a precursor to assisted reproduction techniques such as ICSI. |
| How it is performed | Following surgical extraction and unsuccessful manual sperm search, the specimen is processed using IntelliWell imaging, with sperm identified by AI and confirmed by embryology before cryopreservation or use in ICSI. | Experienced embryologists manually inspect digested or homogenized testicular tissue under a microscope to locate and retrieve sperm for potential use. |
| Evidence status | Currently under investigation; outcomes, including detection rate and impact on ICSI eligibility, will be reported after the trial is completed. | Published studies show that manual sperm retrieval after microdissection testicular sperm extraction achieves success rates between 30% and 50% in non-obstructive azoospermia, with rates highly dependent on underlying histology and operator experience. |
| Important limitations | Efficacy and utility are not yet known; only limited to those cases in which standard manual search yields no sperm, and results will be subject to successful confirmation by embryologists before use in ICSI. | Manual search can be extremely time-consuming and technically challenging, especially when sperm are ultra-rare. Low retrieval rates in certain patients may lead to sperm discard and failed ICSI cycles. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From surgery until day of ICSI
Participants have testicular tissue surgically extracted and processed with the IntelliWell device to identify rare sperm. Verified sperm may be cryopreserved and later thawed for use in ICSI.
Surgical procedure and ICSI day visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Aaron M Bernie, Douglas A Mata, Ranjith Ramasamy...
https://pubmed.ncbi.nlm.nih.gov/26263080/Alexandra Joice Berger, Valary Raup, Ramy Abou Ghayda...
https://pubmed.ncbi.nlm.nih.gov/32793376/Martin Kathrins, Nikita Abhyankar, Ohad Shoshany...
https://pubmed.ncbi.nlm.nih.gov/28483505/Brigham and Women's Hospital
Lead Sponsor
