Testing Performance and Usability of Q300 Device

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901572
• Other study ID #: QISI-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 4, 2023

Study information

• Verified date: June 2023
• Source: QART Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• QISI device
QISI device will simulate its use in ICSI procedures and evaluate sperm cells according to WHO guidelines.

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Wolfson Medical Center	H_olon
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
QART Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate agreement between the Q300 results to the reference method	Demonstrate agreement between Q300 results, and Chemically stained image. the Q300 results will be provided automatically for each individual cell that will be images by the system, the reference method measurements will be provided by core lab embryologist and using a marking tool application.	1 Day
Primary	evaluate the repeatability of the Q300 device results and compare it to the reference method repeatability.	repeatability of bot the device measurements and the reference method will be evaluated and compared.	1 Day
Primary	agreement of individual sperm cell's classification will be compared between the Q300 device and the reference method.	agreement of individual sperm cell's classification (comply with WHO2021 criteria or non comply) will be compared between the Q300 device automatic results and the reference method results.	1 Day
Secondary	Usability of the Q300 device will be evaluated	Usability of the Q300 device will be evaluated using usability questionnaire.	1 Day