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Completed

NCT Number: NCT04901572

Testing Performance and Usability of Q300 Device

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).

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Barzilai Medical Center, Ashkelon, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

QISI device

Diagnostic Test

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

Primary outcomes

  1. Demonstrate agreement between the Q300 results to the reference method

    Time frame: 1 Day

    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.

  2. evaluate the repeatability of the Q300 device results and compare it to the reference method repeatability.

    Time frame: 1 Day

    repeatability of bot the device measurements and the reference method will be evaluated and compared.

  3. agreement of individual sperm cell's classification will be compared between the Q300 device and the reference method.

    Time frame: 1 Day

    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.

Secondary outcomes

  1. Usability of the Q300 device will be evaluated

    Time frame: 1 Day

    Usability of the Q300 device will be evaluated using usability questionnaire.

Sponsors and collaborators

Lead sponsor

QART Medical

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 25, 2021
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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