Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06232720
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be an open label study, non-controlled and non-randomized.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-07-03', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability', 'timeFrame': '1 year', 'description': 'Usability surveys to users including user manual comprehensiveness questionnaire (evaluation of critical steps in the procedure, correct use, feedback on training provided).'}, {'measure': 'Usable blastocyst formation rate', 'timeFrame': '5 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['to Aid in Sperm Selection for ICSI']}, 'referencesModule': {'references': [{'pmid': '40495170', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '40124653', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.', 'detailedDescription': "Testing the Usability of the Q300™ device.\n\nSpecific objectives of this evaluation are as follows:\n\n* Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application.\n* Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device.\n* Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use.\n* Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells.\n* Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations.\n* Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells.\n* Evaluate effect of using the Q300 on the clinical outcome"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient intended for ICSI recruited from the hospital's IVF (both male and female are considered patients in this study).\n* Male, Age \\>18 yrs\n* Female age \\< 40 yrs\n* Patients signed informed consent prior study procedures.\n* Fresh Oocytes\n* Fresh ejaculated motile sperm and presence of motile sperm at the time of sperm selection for ICSI\n* Fresh oocytes\n* Non severe male factor (TMC\\>1\\*10\\^6/mL)\n* Unexplained factor infertility\n* AFC \\>=13mm during ovarian stimulation prior to ovulation trigger or induction#\\>=5 in the cycle\n\nExclusion Criteria:\n\n* Frozen spermatozoa\n* Immotile sperm\n* Severe Oligozoospermia (less than 1 million sperm cells after preparation).\n* Spermatozoa extracted by TESA/ TESE\n* Frozen oocytes\n* 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\n* That the instructions for use of Q300TM have not been fully followed (poor quality of images etc…)\n* Inability to reliably trace sperm-oocyte-embryo clinical outcome throughout the process."}, 'identificationModule': {'nctId': 'NCT06232720', 'briefTitle': 'User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'QART Medical'}, 'officialTitle': 'Q300 User Site Testing Study', 'orgStudyIdInfo': {'id': 'Q300-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Q300 QART Medical', 'type': 'DEVICE', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ashkelon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yulia Michaelov, Dr.', 'role': 'CONTACT'}], 'facility': 'Barzilay Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}], 'centralContacts': [{'name': 'Orly Schwartz', 'role': 'CONTACT', 'email': 'orlyschwartz@qart-medical.com', 'phone': '0545936673'}], 'overallOfficials': [{'name': 'Orly Schwartz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QART Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QART Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}