Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00823602
Status:
UNKNOWN
Last Update Posted:
2009-01-15
First Post:
2009-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D002064', 'term': 'Buserelin'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'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': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-14', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '2weeks'}], 'secondaryOutcomes': [{'measure': 'ovarian stimulation', 'timeFrame': '10days'}]}, 'conditionsModule': {'keywords': ['GnRH antagonist', 'GnRH agonist', 'pregnancy rate', 'Ovarian stimulation'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique.\n\nThis prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART.\n\nThe investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first cycle of ART\n* age \\< 35 years\n* basal FSH \\< 10 IU/L\n\nExclusion Criteria:\n\n* previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis\n* only one ovary'}, 'identificationModule': {'nctId': 'NCT00823602', 'briefTitle': 'Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH', 'organization': {'class': 'OTHER', 'fullName': 'Yazd Research & Clinical Center for Infertility'}, 'officialTitle': 'Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART', 'orgStudyIdInfo': {'id': '1387YAZDRCCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'GnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation', 'interventionNames': ['Drug: ganirelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'GnRH agonist, suprefact, stimulation with a standard long protocol', 'interventionNames': ['Drug: suprefact']}], 'interventions': [{'name': 'ganirelix', 'type': 'DRUG', 'description': 'These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).', 'armGroupLabels': ['1']}, {'name': 'suprefact', 'type': 'DRUG', 'description': 'GnRH agonist, standard protocol', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yazd', 'state': 'Yazd Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'razieh firouzabadi, MD', 'role': 'CONTACT', 'email': 'dr_firouzabadi@yahoo.com', 'phone': '8247085', 'phoneExt': '+98351'}, {'name': 'shahnaz Ahmadi, MD', 'role': 'CONTACT', 'email': 'AHMADISHAHNAZ2005@yahoo.com', 'phone': '9173717981', 'phoneExt': '+98'}, {'name': 'shahnaz ahmadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yazd Research and Clinical Center For Infertility', 'geoPoint': {'lat': 31.89722, 'lon': 54.3675}}], 'centralContacts': [{'name': 'razieh firouzabadi, MD', 'role': 'CONTACT', 'email': 'dr_firouzabadi@yahoo.com', 'phone': '8247085', 'phoneExt': '+98351'}, {'name': 'shahnaz Ahmadi, MD', 'role': 'CONTACT', 'email': 'AHMADISHAHNAZ2005@yahoo.com', 'phone': '9173717981', 'phoneExt': '+98'}], 'overallOfficials': [{'name': 'razieh firouzabadi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yazd Research & Clinical Center for Infertility'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yazd Research & Clinical Center for Infertility', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Razieh Dehghani Firouzabadi', 'oldOrganization': 'Yazd Research & Clinical Center for Infertility'}}}}