Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 3:39 AM
Study NCT ID:
NCT00561769
Status:
COMPLETED
Last Update Posted:
2007-11-21
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Luteal Phase Commencing of Growth Hormone
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-20', 'studyFirstSubmitDate': '2007-11-19', 'studyFirstSubmitQcDate': '2007-11-20', 'lastUpdatePostDateStruct': {'date': '2007-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mature oocyte number', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['poor responder', 'growth hormone', 'luteal'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is being gathered may increase mature oocytes in poor responder'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'poor response to previous COH in the same center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poor responder\n\nExclusion Criteria:\n\n* FSH \\>20 IU'}, 'identificationModule': {'nctId': 'NCT00561769', 'briefTitle': 'Luteal Phase Commencing of Growth Hormone', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'Growth Hormone co-Treatment Within a GnRH Agonist Long Protocol in Patients With Poor Ovarian Response', 'orgStudyIdInfo': {'id': 'GATA 2005-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'poor responder', 'interventionNames': ['Drug: Norditropin pen']}], 'interventions': [{'name': 'Norditropin pen', 'type': 'DRUG', 'description': '12 IU per day', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16200', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Ren Tıp ART Center', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Tansu Kucuk, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GATA Ankara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ren-Tıp ART Center, Bursa, Turkey', 'class': 'UNKNOWN'}]}}}