Overview
User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.
Description
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
Eligibility
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.