Testing Performance and Usability of Q-Art System Imaging Data (QART Sperm Morphology) vs. Reference Staining Methods (Label Sperm Morphology).
Study Details
Study Description
Brief Summary
A data collection clinical study performed on live human spermatozoa samples. Spermatozoa are imaged by QART QISITM microscopy system. For the feasibility 1st phase of the study, up to 40 donors are expected to participate. Study group will include sperm samples donated by the clinic's patients (recruited by the investigators from the clinic's patient database) and/or by healthy volunteers (responding to advertisement).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Cells will be individually selected by the system, and will be representative of the cell population to be selected in ICSI procedures. Each selected cell will be imaged by the QART system and independently and blindly reviewed by an Embryologist(s) team. According to these, each cell will be scored as 'Normal' or 'Abnormal' per WHO guidelines. Sperm cells that were successfully imaged with QISI, will be individually stained. Each stained cell will be imaged by BFM and the non-labeled image will be digitally stored (BFM-NL). The BFM-NL Image will be independently and blindly reviewed by an Embryologist team and scored as 'Normal' or 'Abnormal' per their best discretion.
The database generated in this study will be used for (i) testing the performance accuracy of the QISI system for sperm cell dimensional measurements, (ii) providing feedback to the study sponsor (QART Medical Ltd.) regarding the usability of the QISI system, (iii) further improving and testing the accuracy of the QART Feature Extraction algorithms and (v) assisting in determining the inclusion/exclusion criteria for subsequent clinical stages. In final validation stages, the conventional staining results will be statistically compared with the QISI feature extraction results for each individual sperm cell. During the study, ICSI laboratory personnel (at least 10) will evaluate the suggested use scenarios of the device; device components and user interface, the simplicity of use, duration of use, level of expertise required from the QISI operator, clarity in the use sequences, and perceived added complexity compared with contemporary ICSI routine.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: QART Imaging Cells will be individually selected with the system's micromanipulator under bright-field imaging. The cells will be representative of the cell population to be selected in ICSI procedures, covering the entire range of human sperm cell dimensions. Each selected cell will be simultaneously imaged by the QART system in two modalities: Standard brightfield. QART's imaging methodology. |
Diagnostic Test: QISI device
QISI device will simulate its use in ICSI procedures and evaluate sperm cells according to WHO guidelines.
|
Outcome Measures
Primary Outcome Measures
- Demonstrate correlation for WHO measurements [1 Day]
Demonstrate agreement and correlation between QISI Image map, and Chemically stained image, per Embryologist visual assessment of both images for each WHO2010 measurements.
- Evaluate the usability of the QISI system in a simulated use environment using a usability questionnaire score [1 Day]
Each Embryologist will fill a usability questionnaire following the first 3 reads to evaluate user satisfaction with the device.
- Number and percent of use-related hazards occurring at any point during the study, assessed by device malfunction log [1 Day]
Use-related hazard will be documented in the study's device malfunction log and will be summarized descriptively.
Secondary Outcome Measures
- Correlation between QISI and BF (of stained) for each WHO2010 measurements [1 Day]
Correlation between QISI and BF (of stained) for each WHO2010 measurements: Head width, Head length, Head area, Acrosome area and Nucleus area.
- Agreement rate between QISI and Embryologist on the classification of cells as normal/abnormal [1 Day]
The QISI classification of cells (normal/abnormal), as based on WHO2010 criteria, will be compared to the Embryologist assessment of non-stained cells.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy volunteers
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Patients recruited from the hospital's andrology/IVF departments
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Male, Age >18
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Patient signed on informed consent
Exclusion Criteria:
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Severe Oligozoospermia (less than 1 million sperm cells after preparation).
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Documented presence of infectious disease transmitted in sperm fluids (e.g. HIV, HBV, HCV, Covid-19)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- QART Medical
- Technostat
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QISI-01