User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use

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

Inclusion Criteria:

• Patient intended for ICSI recruited from the hospital's IVF (both male and female are considered patients in this study).
• Male, Age >18 yrs
• Female age < 40 yrs
• Patients signed informed consent prior study procedures.
• Fresh Oocytes
• Fresh ejaculated motile sperm and presence of motile sperm at the time of sperm selection for ICSI
• Fresh oocytes
• Non severe male factor (TMC>1*10^6/mL)
• Unexplained factor infertility
• AFC >=13mm during ovarian stimulation prior to ovulation trigger or induction#>=5 in the cycle

Exclusion Criteria:

• Frozen spermatozoa
• Immotile sperm
• Severe Oligozoospermia (less than 1 million sperm cells after preparation).
• Spermatozoa extracted by TESA/ TESE
• Frozen oocytes
• Egg or ovulatory female factor such as low ovarian reserve (menstrual cycle, per AFC. AMH test- if performed) or non-typical eggs or eggs with severe pathology (qualitative; please find
• That the instructions for use of Q300TM have not been fully followed (poor quality of images etc…)
• Inability to reliably trace sperm-oocyte-embryo clinical outcome throughout the process.