Clinical trial NCT06232720: User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use
Official title: Q300 User Site Testing Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: to Aid in Sperm Selection for ICSI
Lead sponsor: QART Medical
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be an open label study, non-controlled and non-randomized.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Usability
timeFrame: 1 year
measure: Usable blastocyst formation rate
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilay Medical Center
Study officials:
affiliation: QART Medical
name: Orly Schwartz
role: STUDY_DIRECTOR
References: