Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-02-02 @ 1:24 PM
Study NCT ID:
NCT01872559
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3 Dimensional Sonography Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IVF performance', 'timeFrame': '3 weeks', 'description': 'Correlations for age of patient, BMI, documented 2-dimensional sonographic analysis, type of oocyte maturation trigger, serum estradiol prior to trigger, serum estradiol after trigger, number of oocyte retrieved, number of mature oocytes retrieved, embryo grade, type of incubator utilized, day 3 or day 5 transfer, implantation rate, and ultimate pregnancy will be made with the volumetric analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['New Imaging Modality']}, 'descriptionModule': {'briefSummary': "The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is currently in place. Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do no require any additional sonograms, tests, or interventions. All patients are eligible (oocyte donors and autologous oocyte patients) and only patients with a serum estradiol \\> 2000pg/ML will be enrolled in the study. After the additional measurements are obtained, the results will be digitally stored. The results of the 3D sonographic volumetric analysis will then be correlated with the patients' IVF performance.", 'detailedDescription': "The benefits of the study is that 3-dimensional sonographic volumetric analysis may be a superior imaging modality for sonographically assessing oocyte maturity and may lead to change in clinical practice. The lone risk of the study is rooted in protecting the patients' protected health information."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In Vitro fertilization patients and donor egg patients of the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine who at the day of monitoring (having an ultrasound and blood work drawn) have an estradiol level greater than 2000pg/ML.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients (oocyte donors and autologous oocyte patients)with a serum estradiol \\> 2000pg/ML.\n\nExclusion Criteria:\n\n* All patients not meeting the estradiol criteria.'}, 'identificationModule': {'nctId': 'NCT01872559', 'briefTitle': '3 Dimensional Sonography Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': '3D Sonographic Volumetric Analysis of Ovarian Follicles.', 'orgStudyIdInfo': {'id': '1209013095'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3D sonographic analysis', 'description': 'The study is designed to evaluate a new imaging modality, 3D sonographic volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is currently in place. Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do no require any additional sonograms, tests, or interventions.', 'interventionNames': ['Other: 3D Sonography analysis']}], 'interventions': [{'name': '3D Sonography analysis', 'type': 'OTHER', 'description': 'Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do not require any additional sonograms, tests, or interventions.', 'armGroupLabels': ['3D sonographic analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Glenn Schattman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}