Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-03 @ 11:04 PM
Study NCT ID:
NCT01773603
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2013-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020669', 'term': 'Fetoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'No statistical difference observed for outcomes.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blastocyst formation rate', 'timeFrame': '5th day of embryonic development'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '7th week of pregnancy', 'description': 'Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first βhCG test, which was performed 14 days after oocyte retrieval.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Time-lapse', 'morphokinetics', 'blastocyst transfer', 'eSET'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.\n\nThis study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in their first or second ART treatment cycle\n* no recurrent spontaneous abortions\n* age\\<35 years\n* BMI\\<28 kg/m2\n* ≥8 oocytes retrieved\n\nExclusion Criteria:\n\n* severe endometriosis\n* polycystic ovary syndrome\n* hydrosalpynx\n* uterine pathology\n* severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)\n* very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)'}, 'identificationModule': {'nctId': 'NCT01773603', 'briefTitle': 'Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sisli Hospital, Istanbul'}, 'officialTitle': 'Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer', 'orgStudyIdInfo': {'id': 'MC0405'}, 'secondaryIdInfos': [{'id': 'IMH2013-1', 'type': 'OTHER', 'domain': 'Sisli Memorial Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional incubation', 'description': 'Five-day embryo culture in conventional incubators'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Embryoscope', 'description': 'Five-day embryo culture in embryoscope which is an incubator with a built-in camera', 'interventionNames': ['Device: Embryoscope']}], 'interventions': [{'name': 'Embryoscope', 'type': 'DEVICE', 'otherNames': ['Time-lapse monitoring of human embryos in Embryoscope'], 'description': 'Five-day embryo culture in embryoscope which is an incubator with a built-in camera', 'armGroupLabels': ['Embryoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34385', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sisli Memorial Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Semra Kahraman, MD, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sisli Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Murat Çetinkaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'R&D Laboratory Manager', 'investigatorFullName': 'Dr. Murat Çetinkaya', 'investigatorAffiliation': 'Memorial Sisli Hospital, Istanbul'}}}}