Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-02 @ 5:55 PM
Study NCT ID:
NCT00480103
Status:
TERMINATED
Last Update Posted:
2011-03-04
First Post:
2007-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrauterine Embryo Development With ANECOVA Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'whyStopped': 'INHERENT MODIFICATIONS NEEDED BEFORE PROCEEDING', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-03', 'studyFirstSubmitDate': '2007-05-28', 'studyFirstSubmitQcDate': '2007-05-29', 'lastUpdatePostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Embryo morphological and chromosomal features', 'Implantation and pregnancy rate'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19273881', 'type': 'DERIVED', 'citation': 'Blockeel C, Mock P, Verheyen G, Bouche N, Le Goff P, Heyman Y, Wrenzycki C, Hoffmann K, Niemann H, Haentjens P, de Los Santos MJ, Fernandez-Sanchez M, Velasco M, Aebischer P, Devroey P, Simon C. An in vivo culture system for human embryos using an encapsulation technology: a pilot study. Hum Reprod. 2009 Apr;24(4):790-6. doi: 10.1093/humrep/dep005. Epub 2009 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'We aim to compare the morphological and chromosomal features of human embryos cultured In Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as well as implantation and pregnancy rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age below 37\n* Hormonal serum levels within normal ranges (FSH, LH, E2, PRL, P4, T4, TSH)\n* Negative serologic screening for HIV, Hep B and C\n* No uterine or ovarian alterations found by ultrasound\n* Normal BMI (19 - 29 kg/m2).\n\nExclusion Criteria:\n\n* At least 8 stage MII oocytes are not retrieved\n* Endometriosis or PCO\n* Severe male factor in the partner'}, 'identificationModule': {'nctId': 'NCT00480103', 'acronym': 'ANECOVA', 'briefTitle': 'Intrauterine Embryo Development With ANECOVA Device', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': "Multi-Center Evaluation Program NCVD1H Intrauterine Embryo'S Development Assisted by ANECOVA ACVd1 Device", 'orgStudyIdInfo': {'id': 'NCVD1H'}}, 'armsInterventionsModule': {'interventions': [{'name': 'in vivo (ANECOVA D-1) or in vitro culture in 25-µl droplets of cleavage medium (Medicult®) under paraffin oil', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Infertilidad Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Martin Velasco', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Affiliated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anecova SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr Carlos Simon', 'oldOrganization': 'Instituto Valenciano de Infertilidad'}}}}