Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-03-03 @ 3:05 PM
Study NCT ID:
NCT01671657
Status:
UNKNOWN
Last Update Posted:
2015-10-20
First Post:
2012-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
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': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2012-08-21', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of implantation', 'timeFrame': '5-6 gestational age', 'description': 'To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).'}], 'secondaryOutcomes': [{'measure': 'To evaluate clinical pregnancy rates from the Eeva Test group to the Control group', 'timeFrame': '5-6 weeks gestational age'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': 'Gestational age week 8-12'}, {'measure': 'Multiple pregnancy rate', 'timeFrame': 'Gestational age weeks 5-6 and 8-12'}, {'measure': 'Spontaneous miscarriage rate', 'timeFrame': 'Gestational age week 8-12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In vitro fertilization', 'Assisted reproductive therapy', 'Time-lapse image recording', 'Image analysis software'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '26604069', 'type': 'DERIVED', 'citation': 'Adamson GD, Abusief ME, Palao L, Witmer J, Palao LM, Gvakharia M. Improved implantation rates of day 3 embryo transfers with the use of an automated time-lapse-enabled test to aid in embryo selection. Fertil Steril. 2016 Feb;105(2):369-75.e6. doi: 10.1016/j.fertnstert.2015.10.030. Epub 2015 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.', 'detailedDescription': 'The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.\n* IVF cycle attempts ≤ 2.\n* Egg age ≤ 40 years.\n* Planned Day 3 embryo transfer.\n* At least 4 normally fertilized eggs (2PN).\n* All 2PN embryos must be imaged by Eeva.\n* Ejaculated sperm or sperm from the epididymis (fresh or frozen).\n* Willing to comply with study protocol and procedures.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Planned preimplantation genetic diagnosis or preimplantation genetic screening.\n* Planned "freeze all" cycle (oocytes or embryos).\n* Sperm retrieved from testicular tissue.\n* Abnormal uterine cavity as evaluated by standard methods.\n* Gestational carrier.\n* Endometriosis\n* Hydrosalpinx.\n* History of cancer.\n* Concurrent participation in another clinical study.'}, 'identificationModule': {'nctId': 'NCT01671657', 'acronym': 'US EPIC', 'briefTitle': 'US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Progyny, Inc.'}, 'officialTitle': 'US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)', 'orgStudyIdInfo': {'id': '2012-AUX-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Eeva Test Group', 'description': 'Day 3 embryo transfers that used Eeva with morphology grading (Test Group).'}, {'label': 'Matched case control group', 'description': 'Day 3 embryo transfers using morphology grading only (from concurrent Control Group).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Fertility Physicians of Northern California', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Shehua Shen, MD, ELD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Progyny, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Progyny, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}