Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-08 @ 12:03 AM
Study NCT ID:
NCT01107002
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2010-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-14', 'studyFirstSubmitDate': '2010-04-17', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy rate', 'timeFrame': '6-8 weeks after oocyte retrieval'}, {'measure': 'Live birth rate', 'timeFrame': 'After 37 weeks of gestational age'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '4 weeks after embryo transfer'}, {'measure': 'Miscarriage rate', 'timeFrame': '18 weeks after fertilization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infertility', 'Embryo transfer'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures', 'detailedDescription': 'A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment.\n\nThe study protocol will be assessed by an independent institutional review board and Royan ethics committee.\n\nOvarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.\n\nMain outcome measures will be implantation, clinical pregnancy and live birth rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age fewer than 40\n* Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy\n* Two previous or more failed IVF/ICSI cycles\n\nExclusion Criteria:\n\n* Women with submucous myoma\n* Women with intra mural or subserous myoma greater than 3 cm\n* Women with Endometriosis or Endometrioma\n* Hydrosalpinx'}, 'identificationModule': {'nctId': 'NCT01107002', 'briefTitle': 'Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients Who Failed to Conceive in Two or More Day 2-3 Embryo Transfer Cycle in Royan Institute', 'orgStudyIdInfo': {'id': 'Royan-Emb-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day 5 embryo transfer group', 'description': 'Embryo will transfer at blastocyst stage (day 5 after ovum pick up)', 'interventionNames': ['Procedure: Day 5 embryo transfer group']}], 'interventions': [{'name': 'Day 5 embryo transfer group', 'type': 'PROCEDURE', 'description': 'Embryo will transfer at blastocyst stage (day 5 after ovum pick up)', 'armGroupLabels': ['Day 5 embryo transfer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19395-4644', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mahnaz Ashrafi,, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royan Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Hamid Gourabi, Chief', 'oldOrganization': 'Royan Institute'}}}}