Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-31 @ 3:53 PM
Study NCT ID:
NCT01569256
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2012-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Hyperstimulation Syndrome and Cabergoline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-03', 'studyFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations of follicular fluid AMH', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Concentrations of follicular fluid inhibin B', 'timeFrame': '1 year'}, {'measure': 'Concentrations of follicular fluid HGF', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Polycystic Ovarian Syndrome', 'Ovarian Hyperstimulation Syndrome']}, 'descriptionModule': {'briefSummary': 'Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).', 'detailedDescription': 'Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.\n* Having the criteria of PCOS\n\nExclusion Criteria:\n\n* Not having the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT01569256', 'briefTitle': 'Ovarian Hyperstimulation Syndrome and Cabergoline', 'organization': {'class': 'OTHER', 'fullName': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital"}, 'officialTitle': 'The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss', 'orgStudyIdInfo': {'id': 'ESG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cabergoline administered group', 'description': 'The patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS.\n\nAll patients were administered long luteal protocol for ovulation induction.', 'interventionNames': ['Drug: Cabergoline']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group.\n\nAll patients were administered long luteal protocol for ovulation induction.'}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'otherNames': ['Dostinex'], 'description': 'Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days', 'armGroupLabels': ['Cabergoline administered group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emine Seda Guvendag Guven, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rize University, Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Etlik Zubeyde Hanim Womens' Health and Teaching Hospital", 'class': 'UNKNOWN'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Assoc. Prof. Emine Seda Guvendag Guven', 'investigatorAffiliation': "Etlik Zubeyde Hanim Womens' Health and Teaching Hospital"}}}}