Viewing Study NCT01137461


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Study NCT ID: NCT01137461
Status: COMPLETED
Last Update Posted: 2011-04-14
First Post: 2010-06-03
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-13', 'studyFirstSubmitDate': '2010-06-03', 'studyFirstSubmitQcDate': '2010-06-03', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '40 days after embryo transfer', 'description': 'Evidence of gestational sac by transvaginal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Female infertility with indication of oocyte reception'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '21459374', 'type': 'RESULT', 'citation': 'Bodri D, Colodron M, Garcia D, Obradors A, Vernaeve V, Coll O. Transvaginal versus transabdominal ultrasound guidance for embryo transfer in donor oocyte recipients: a randomized clinical trial. Fertil Steril. 2011 Jun;95(7):2263-8, 2268.e1. doi: 10.1016/j.fertnstert.2011.03.028. Epub 2011 Apr 2.'}], 'seeAlsoLinks': [{'url': 'http://www.eugin.es/', 'label': 'Clínica EUGIN'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oocyte recipients.\n* Uterus without previously detected anomalies.\n* Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.\n\nExclusion Criteria:\n\n* Turner syndrome, Black race (significantly lower implantational rates)'}, 'identificationModule': {'nctId': 'NCT01137461', 'briefTitle': 'Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Privada Eugin'}, 'officialTitle': 'Evaluation of Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Recipients of Oocytes. A Single-centre, Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'TATV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'abdominal ultrasound', 'description': 'traditional technique', 'interventionNames': ['Procedure: ultrasound-guided embryo transfer']}, {'type': 'OTHER', 'label': 'transvaginal ultrasound', 'description': 'new technique', 'interventionNames': ['Procedure: ultrasound-guided embryo transfer']}], 'interventions': [{'name': 'ultrasound-guided embryo transfer', 'type': 'PROCEDURE', 'description': 'Embryo transfer in oocyte recipients', 'armGroupLabels': ['abdominal ultrasound', 'transvaginal ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08029', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Clinica EUGIN', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Daniel Bodri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica EUGIN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Privada Eugin', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Daniel Bodri / Principal investigator', 'oldOrganization': 'Clinica EUGIN'}}}}