Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06088693
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009845', 'term': 'Oligospermia'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator blind the participant allocation'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm analysis', 'timeFrame': 'Before Treatment in day 1, After 30 days of treatment.', 'description': 'Spermatozoa/mL'}, {'measure': 'SOD Spermatozoa', 'timeFrame': 'Before Treatment in day 1, After 30 days of treatment.', 'description': 'Superokside Dismutase in Spermatozoa'}, {'measure': 'SOD Plasma Semen', 'timeFrame': 'Before Treatment in day 1, After 30 days of treatment.', 'description': 'Superokside Dismutase in Plasma Semen'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oligozoospermia', 'Oligoasthenozoospermia', 'Oligoasthenoteratozoospermia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare in Oligozoospermia Patient. The main questions it aims to answer are: 1. Electroacupuncture therapy and standard therapy can affect oligozoospermia. 2. Electroacupuncture therapy and standard therapy can affect semen and spermatozoa plasma SOD levels.\n\nResearchers will compare patient with standard therapy with patient with standard therapy with electroacupuncture.', 'detailedDescription': '1. Male subjects aged more than 25 years and less than 45 years.\n2. Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (\\<5 million spermatozoa/mL).\n3. Willing to take part in research and sign informed consent.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Male with Oligozoospermia, Oligoasthenozoospermia, Oligoasthenoteratozoospermia, Oligoteratozoospermia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male 25 to 45 years old.\n* Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (\\<5 million spermatozoa/mL).\n* Willing to participate in research and sign informed consent.\n\nExclusion Criteria:\n\n* Emergency case patient / bleeding disorders\n* Have a tumor, scar tissue or infected wound in the area where the acupuncture needle will be inserted.\n* Alcoholic\n* Using a pacemaker (heart pacemaker).\n* Azoospermia\n* Varicocele'}, 'identificationModule': {'nctId': 'NCT06088693', 'briefTitle': 'The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.', 'orgStudyIdInfo': {'id': '23-06-1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients diagnosed with Oligozoospermia who only receive standard therapy from an Andrologist as a standard therapy.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients diagnosed with Oligozoospermia receive standard therapy from an Andrologist and Electroacupuncture.', 'interventionNames': ['Other: Electroacupuncture and Standard Therapy']}], 'interventions': [{'name': 'Electroacupuncture and Standard Therapy', 'type': 'OTHER', 'description': 'Acupuncture Needle Insertion with Electroacupuncture machine.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Jakarta', 'state': 'Jakarta Timur', 'country': 'Indonesia', 'facility': 'Lisa Yunita', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Lisa Yunita', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Lisa Yunita', 'investigatorAffiliation': 'Indonesia University'}}}}