to Aid in Sperm Selection for ICSI
Conditions
Brief summary
User Site Testing Study to evaluate usability of the Q300™ device under real-life conditions in a reproductive laboratory environment use.
Detailed 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
Interventions
DEVICEQ300 QART Medical
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
Sponsors
QART Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be an open label study, non-controlled and non-randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability | 1 year | Usability surveys to users including user manual comprehensiveness questionnaire (evaluation of critical steps in the procedure, correct use, feedback on training provided). |
| Usable blastocyst formation rate | 5 days | 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. |
Countries
Israel
Contacts
Primary ContactOrly Schwartz
Outcome results
None listed