User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.
Testing the Usability of the Q300™ device. Specific objectives of this evaluation are as follows: * Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application. * Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device. * Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use. * Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells. * Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations. * Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells. * Evaluate effect of using the Q300 on the clinical outcome
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The Q300TM Imaging system includes a Quantitative Phase Microscope. Q300TM uses a low intensity coherent light source, in a uniquely configured interferometer, which measures light delay as it passes different locations across the sperm cell. The amount
Barzilay Medical Center
Ashkelon, Israel
RECRUITINGUsability
Usability surveys to users including user manual comprehensiveness questionnaire (evaluation of critical steps in the procedure, correct use, feedback on training provided).
Time frame: 1 year
Usable blastocyst formation rate
Number of usable (transferred or frozen) embryos per cycle (Gardner 2BB at day 5 or equivalent or grade "good" according to Istanbul consensus for cleavage-stage.
Time frame: 5 days
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