Healthy Clinical Trial
Official title:
Feasibility Clinical Study for Testing Performance and Usability of Q300 Device (QART Sperm Morphology) vs. Reference Staining Methods in Laboratory Environment Simulating Pre-ICSI Sperm Imaging of Live Sperm Cells.
NCT number | NCT04901572 |
Other study ID # | QISI-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2021 |
Est. completion date | April 4, 2023 |
Verified date | June 2023 |
Source | QART Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A data collection clinical study performed on live human spermatozoa samples. Spermatozoa are imaged by QART Q300TM microscopy system. For the feasibility 1st phase of the study, up to 75 donors are expected to participate. Study group will include sperm samples donated by the clinic's patients (recruited by the investigators from the clinic's patient database) and/or by healthy volunteers (responding to advertisement).
Status | Completed |
Enrollment | 75 |
Est. completion date | April 4, 2023 |
Est. primary completion date | April 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Healthy volunteers 2. Patients recruited from the hospital's andrology/IVF departments 3. Male, Age >18 4. Patient signed on informed consent Exclusion Criteria: 1. Severe Oligozoospermia (less than 1 million sperm cells after preparation). 2. Documented presence of infectious disease transmitted in sperm fluids (e.g. HIV, HBV, HCV, Covid-19) |
Country | Name | City | State |
---|---|---|---|
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Wolfson Medical Center | H_olon | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
Israel | Meir Medical Center | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
QART Medical |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demonstrate agreement between the Q300 results to the reference method | Demonstrate agreement between Q300 results, and Chemically stained image. the Q300 results will be provided automatically for each individual cell that will be images by the system, the reference method measurements will be provided by core lab embryologist and using a marking tool application. | 1 Day | |
Primary | evaluate the repeatability of the Q300 device results and compare it to the reference method repeatability. | repeatability of bot the device measurements and the reference method will be evaluated and compared. | 1 Day | |
Primary | agreement of individual sperm cell's classification will be compared between the Q300 device and the reference method. | agreement of individual sperm cell's classification (comply with WHO2021 criteria or non comply) will be compared between the Q300 device automatic results and the reference method results. | 1 Day | |
Secondary | Usability of the Q300 device will be evaluated | Usability of the Q300 device will be evaluated using usability questionnaire. | 1 Day |
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