Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT01403532
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2011-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Therapy for Hypogonadotropic Hypogonadism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D017436', 'term': 'Kallmann Syndrome'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D058490', 'term': 'Disorder of Sex Development, 46,XY'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-10', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm density ≥1,000,000/ml', 'timeFrame': 'One and a half year', 'description': 'The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypogonadotropic Hypogonadism', 'Kallmann Syndrome', 'LH', 'FSH'], 'conditions': ['Hypogonadotropic Hypogonadism', 'Kallmann Syndrome']}, 'referencesModule': {'references': [{'pmid': '25825944', 'type': 'DERIVED', 'citation': 'Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical hypogonadotropic hypogonadism\n* Hormonal levels: Testosterone \\< 1.8ng/ml, LH \\< 2-3 mIU/mL and FSH \\< 2-3 mIU/mL\n* Infantile testis\n* Delayed bone age\n* Normal testing of the anterior pituitary gland\n\nExclusion Criteria:\n\n* Prior therapy with HMG or FSH\n* Severe dysfunction of live and kidney\n* Cryptorchidism or no response to HCG stimulation experiment (Testosterone \\< 1.8ng/ml after HCG stimulation)\n* Another pituitary hormonal deficiency\n* Hypergonadotropic hypogonadism\n* With abnormal karyotype'}, 'identificationModule': {'nctId': 'NCT01403532', 'briefTitle': 'Sequential Therapy for Hypogonadotropic Hypogonadism', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism', 'orgStudyIdInfo': {'id': 'CCEMD005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional', 'interventionNames': ['Drug: Traditional intervention for HH using HCG and FSH']}, {'type': 'EXPERIMENTAL', 'label': 'Sequential', 'interventionNames': ['Drug: Sequential intervention for HH using HCG and FSH']}, {'type': 'EXPERIMENTAL', 'label': 'Sequential Plus', 'interventionNames': ['Drug: Sequential intervention for HH using HCG and FSH plus zinc']}], 'interventions': [{'name': 'Traditional intervention for HH using HCG and FSH', 'type': 'DRUG', 'otherNames': ['Tranditional'], 'description': 'Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;', 'armGroupLabels': ['Traditional']}, {'name': 'Sequential intervention for HH using HCG and FSH', 'type': 'DRUG', 'otherNames': ['Sequential'], 'description': 'Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months', 'armGroupLabels': ['Sequential']}, {'name': 'Sequential intervention for HH using HCG and FSH plus zinc', 'type': 'DRUG', 'otherNames': ['Sequential plus'], 'description': 'Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily', 'armGroupLabels': ['Sequential Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiao-Ying Li, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao-Ying Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}