Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00948805
Status:
UNKNOWN
Last Update Posted:
2009-07-29
First Post:
2009-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-09-07', 'releaseDate': '2011-08-04'}], 'estimatedResultsFirstSubmitDate': '2011-08-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'C412828', 'term': 'Ovidrel'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'C571801', 'term': 'follitropin alfa'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-28', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of functional rescue of corpus luteum', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '6 months'}, {'measure': 'Levels of serum steroids', 'timeFrame': '6 months'}, {'measure': 'Levels of serum gonadotropins', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['corpus luteum rescue', 'Gonadotropin Releasing Hormone (GnRH agonist)', 'human Chorionic Gonadotropin (hCG)', 'infertility', 'pregnancy rate'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fm.usp.br', 'label': 'University of São Paulo web page'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.', 'detailedDescription': 'The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>21 and \\< 38 years old\n* polycystic ovarian syndrome\n* risk for ovarian hyperstimulation syndrome\n\nExclusion Criteria:\n\n* recurrent abortion\n* endometriosis\n* more than 3 IVF failures\n* use of oral contraceptive pills in the preceding 3 months\n* low response to gonadotropins'}, 'identificationModule': {'nctId': 'NCT00948805', 'briefTitle': 'Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment', 'orgStudyIdInfo': {'id': '0555/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GnRH agonist', 'description': '3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.', 'interventionNames': ['Drug: GnRH agonist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': '250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'GnRH agonist', 'type': 'DRUG', 'otherNames': ['Ovidrel', 'Zoladex', 'Gonal'], 'description': '3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation', 'armGroupLabels': ['GnRH agonist']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Zoladex', 'Ovidrel', 'Gonal'], 'description': '250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cláudia Gomes, MD', 'role': 'CONTACT', 'email': 'cgomes@huntington.com.br', 'phone': '551176569373'}, {'name': 'Cláudia Gomes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Cláudia M Gomes, MD', 'role': 'CONTACT', 'email': 'cgomes@huntington.com.br', 'phone': '551130596122'}, {'name': 'André M Rocha, PhD', 'role': 'CONTACT', 'email': 'arocha@huntington.com.br', 'phone': '551130596122'}], 'overallOfficials': [{'name': 'Paulo Serafini, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cláudia Messias Gomes', 'oldOrganization': 'Gynecology of Faculty of Medicine of the University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-08-04', 'type': 'RELEASE'}, {'date': '2011-09-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Claudia Messias Gomes, Obstetric and Gynecology , reproductive medicine especialist, University of Sao Paulo'}}}}