to Aid in Sperm Selection for ICSI Clinical Trial
Official title:
Q300 User Site Testing Study
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 ;