Testing Performance and Usability of Q300 Device

NCT04901572 | Completed

• 1 other identifier: QISI-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 4

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Usability of the Q300 device will be evaluated

  1 Day

Study Arms (1)

QART Imaging

OTHER

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: 1. Standard brightfield. 2. QART's imaging methodology.

Diagnostic Test: QISI device

Interventions

QISI device DIAGNOSTIC_TEST

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

QART Imaging

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• QART Medical: lead

Study Sites (4)

Barzilai Medical Center

Ashkelon, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: September 1, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)