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

QART Medical

Status

Enrolling

Conditions

to Aid in Sperm Selection for ICSI

Treatments

Device: Q300 QART Medical

Study type

Interventional

Funder types

Industry

Identifiers

Q300-02

Details and patient eligibility

About

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

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.