Clinical trial NCT04901572: Testing Performance and Usability of Q300 Device
Official title: Feasibility Clinical Study for Testing Performance and Usability of Q300 Device (QART Sperm Morphology) vs. Reference Staining Methods in Laboratory Environment Simulating Pre-ICSI Sperm Imaging of Live Sperm Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: QART Medical
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Up to 75 sperm samples will be evaluated using the Q300 system and a standard staining method for device feasibility testing. No other groups will be present in this study.
Primary purpose: OTHER

Brief summary: A data collection clinical study performed on live human spermatozoa samples. Spermatozoa are imaged by QART Q300TM microscopy system. For the feasibility 1st phase of the study, up to 75 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).

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 Q300, 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 Q300 system for sperm cell dimensional measurements, (ii) providing feedback to the study sponsor (QART Medical Ltd.) regarding the usability of the Q300 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 Q300 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 Q300 operator, clarity in the use sequences, and perceived added complexity compared with contemporary ICSI routine.

Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers
2. Patients recruited from the hospital's andrology/IVF departments
3. Male, Age \>18
4. Patient signed on informed consent

Exclusion Criteria:

1. Severe Oligozoospermia (less than 1 million sperm cells after preparation).
2. Documented presence of infectious disease transmitted in sperm fluids (e.g. HIV, HBV, HCV, Covid-19)

Primary outcomes:
measure: Demonstrate agreement between the Q300 results to the reference method
timeFrame: 1 Day
measure: evaluate the repeatability of the Q300 device results and compare it to the reference method repeatability.
timeFrame: 1 Day
measure: agreement of individual sperm cell's classification will be compared between the Q300 device and the reference method.
timeFrame: 1 Day
Secondary outcomes:
measure: Usability of the Q300 device will be evaluated
timeFrame: 1 Day
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: H̱olon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References: