Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-28 @ 11:00 PM
Study NCT ID:
NCT02670304
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2013-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-04-19', 'releaseDate': '2016-03-21'}, {'resetDate': '2017-01-31', 'releaseDate': '2016-12-06'}], 'estimatedResultsFirstSubmitDate': '2016-03-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of early OHSS', 'timeFrame': 'up to 1 months'}], 'secondaryOutcomes': [{'measure': 'vascular endothelial growth factor level', 'timeFrame': 'up to 1 months', 'description': 'vascular endothelial growth factor in pg/ml'}, {'measure': 'incidence of hydrothorax', 'timeFrame': 'up to 1 months'}, {'measure': 'incidence of liver dysfunction', 'timeFrame': 'up to 1 months'}, {'measure': 'incidence of renal dysfunction', 'timeFrame': 'up to 1 months'}, {'measure': 'incidence of electrolytic imbalance', 'timeFrame': 'up to 1 months'}, {'measure': 'incidence of hemoconcentration', 'timeFrame': 'up to 1 months'}, {'measure': 'incidence of elevated WBC', 'timeFrame': 'up to 1 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['letrozole', 'ovarian hyperstimulating syndrome'], 'conditions': ['Ovarian Hyperstimulation Syndrome']}, 'descriptionModule': {'briefSummary': 'Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.', 'detailedDescription': 'Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertile women undergoing IVF treatment with more than 25 oocytes collected.\n\nExclusion Criteria:\n\n* letrozole contraindications,e.g. severe hepatic and renal dysfunction'}, 'identificationModule': {'nctId': 'NCT02670304', 'briefTitle': 'Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment', 'orgStudyIdInfo': {'id': '28843020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'letrozole', 'description': 'letrozole for the first day after ovum picked up at least for 5 days.', 'interventionNames': ['Drug: letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aspirin', 'description': 'asprin for the first day after ovum picked up at least for 5 days.', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'letrozole from the day of oocyte retrieval for 5 days', 'armGroupLabels': ['letrozole']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'aspirin from the day of oocyte retrieval for 5 days', 'armGroupLabels': ['aspirin']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to make IPD available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhou Canquan', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-21', 'type': 'RELEASE'}, {'date': '2016-04-19', 'type': 'RESET'}, {'date': '2016-12-06', 'type': 'RELEASE'}, {'date': '2017-01-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zhou Canquan, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University'}}}}