User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use
NCT ID: NCT06232720
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-02-15
2025-03-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Q300 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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QART Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Orly Schwartz
Role: STUDY_DIRECTOR
QART Medical
Locations
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Barzilay Medical Center
Ashkelon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Yulia Michaelov, Dr.
Role: primary
References
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Michailov Y, Amsalem E, Umanski N, Tamadaev V, Friedler S, Saar-Ryss B. Clinical outcome using the Q300 device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study. Reprod Biol Endocrinol. 2025 Jun 10;23(1):90. doi: 10.1186/s12958-025-01424-w.
Michailov Y, Friedler S, Saar-Ryss B. First clinical pregnancy and delivery achieved after using a new 3D imaging technology for sperm selection: a case report. Front Reprod Health. 2025 Mar 7;7:1559684. doi: 10.3389/frph.2025.1559684. eCollection 2025.
Other Identifiers
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Q300-02
Identifier Type: -
Identifier Source: org_study_id
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