Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-28 @ 5:19 PM
Study NCT ID:
NCT01617993
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2012-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'User questionnaire of Eeva System usability and reports of device malfunctions.', 'timeFrame': 'Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['in vitro fertilization', 'assisted reproduction', 'noninvasive imaging of embryos', 'time lapse imaging of embryos', 'traditional morphological grading of embryos', 'prediction of blastocysts', 'infertility', 'Genital Diseases, Male', 'Genital Diseases, Female'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.auxogyn.com', 'label': 'Auxogyn, Inc. website'}]}, 'descriptionModule': {'briefSummary': 'User questionnaire of Eeva System usability and reports of device malfunctions.', 'detailedDescription': 'This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs\n* Subject is ≥ 18 and ≤ 40 years of age.\n* Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.\n* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.\n* Subject has ≥ 5 normally fertilized eggs (2 PN)\n* Willing to have all 2PN embryos monitored by Eeva\n* Willing to comply with study protocol and procedures and able to speak English.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Reinseminated eggs.\n* History of cancer.\n* Gestational carriers.\n* Planned preimplantation genetic diagnosis or preimplantation genetic screening.\n* Previously enrolled in this study\n* Concurrent participation in another clinical study.'}, 'identificationModule': {'nctId': 'NCT01617993', 'acronym': 'CAS', 'briefTitle': 'Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Progyny, Inc.'}, 'officialTitle': 'Eeva Continued Access Study.', 'orgStudyIdInfo': {'id': '2012-AUX-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women undergoing IVF treatment', 'description': 'Women undergoing IVF treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94133', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Fertility Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Fertility Physicians of Northern California', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Reproductive Science Center', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}], 'overallOfficials': [{'name': 'Shehua Shen, ELD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Progyny, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Progyny, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}