Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-04 @ 9:07 PM
Study NCT ID:
NCT01816802
Status:
UNKNOWN
Last Update Posted:
2015-03-26
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2013-03-20', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Multiple Pregnancy Rate', 'timeFrame': '5-6 gestational weeks', 'description': 'Determined by follow-up pregnancy ultrasound outcome'}, {'measure': 'Spontaneous Miscarriage Rate', 'timeFrame': '5-6 gestational weeks', 'description': 'Determined by follow-up pregnancy ultrasound outcome'}], 'primaryOutcomes': [{'measure': 'Clinical Pregnancy Rate', 'timeFrame': '5-6 gestational weeks', 'description': 'Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In vitro fertilization', 'Assisted reproductive therapy', 'Time-lapse image recording', 'Image analysis software'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.auxogyn.com', 'label': 'Auxogyn, Inc. website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.', 'detailedDescription': 'This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing in vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.\n\nExclusion Criteria:\n\n* history of cancer.\n* gestational carrier.'}, 'identificationModule': {'nctId': 'NCT01816802', 'acronym': 'MERGE', 'briefTitle': 'Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Progyny, Inc.'}, 'officialTitle': 'MERGE: MulticEnter ReGistry With Eeva', 'orgStudyIdInfo': {'id': '2012-AUX-009'}, 'secondaryIdInfos': [{'id': 'TST 2193-p', 'type': 'OTHER', 'domain': 'Auxogyn'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'In-vitro fertilization using Eeva', 'description': 'Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.', 'interventionNames': ['Device: In-vitro fertilization using Eeva']}], 'interventions': [{'name': 'In-vitro fertilization using Eeva', 'type': 'DEVICE', 'description': 'Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.', 'armGroupLabels': ['In-vitro fertilization using Eeva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'HRC Fertility', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Fertility and Reproductive Medicine Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Reproductive Partners', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '95124', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Fertility Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Center for Advanced Reproductive Services (UCHC)', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fertility Centers of Illinois - River North', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medical Faculty Foundation', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60035', 'city': 'Highland Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fertility Centers of Illinois, Highland Park IVF Center', 'geoPoint': {'lat': 42.18169, 'lon': -87.80034}}, {'zip': '11747', 'city': 'Melville', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island IVF', 'geoPoint': {'lat': 40.79343, 'lon': -73.41512}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital Fertility Center', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '45209', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Institute for Reproductive Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Fertility Center of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Shehua Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Progyny, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Progyny, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}