Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-06 @ 10:48 PM
Study NCT ID:
NCT02307994
Status:
UNKNOWN
Last Update Posted:
2014-12-08
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009845', 'term': 'Oligospermia'}, {'id': 'D053713', 'term': 'Azoospermia'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm density', 'timeFrame': '6 month'}, {'measure': '(A + B)grade sperm and sperm activity rate', 'timeFrame': '6 month'}, {'measure': 'A grade sperm', 'timeFrame': '6 month'}, {'measure': 'semen volume', 'timeFrame': '6 month'}, {'measure': 'sex hormone levels', 'timeFrame': '6 month'}, {'measure': 'testis volume', 'timeFrame': '6 month'}]}, 'conditionsModule': {'keywords': ['infertility'], 'conditions': ['Oligospermia', 'Azoospermia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male subjects aged 20\\~35.\n* They accorded with diagnostic criteria of severe oligospermia or azoospermia.\n* They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.\n\nExclusion Criteria:\n\n* Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.\n* Subjects addicted to drug，tobacco，or alcohol.\n* Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.\n* Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .\n* Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.\n* Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for infertility .\n* Subjects did not meet the inclusion criteria, did not according to the prescribed medication, were unable to judge the efficacy ,had incomplete information, or affected the efficacy or safety judgment.\n* Subjects were IHH patients"}, 'identificationModule': {'nctId': 'NCT02307994', 'briefTitle': 'Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Livzon Pharmaceutical Group Inc.'}, 'officialTitle': 'Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China', 'orgStudyIdInfo': {'id': 'LIVZON-R-14-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '75IU uFSH', 'description': '75IU uFSH (Livzon Pharm Group Inc., China) being injected into severe oligospermia patients or azoospermia patients every 3 days for 6 months', 'interventionNames': ['Drug: 75IU uFSH']}], 'interventions': [{'name': '75IU uFSH', 'type': 'DRUG', 'armGroupLabels': ['75IU uFSH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Hui Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Livzon Pharmaceutical Group Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}