Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-02 @ 10:53 PM
Study NCT ID:
NCT03627533
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'electroacupuncture versus sham electroacupuncture'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Index apoptotic (Ratio Bax/Bcl-2) of granulosa cells, GDF9 and BMP15', 'timeFrame': '"up to 1 months"', 'description': 'Bax/Bcl-2 is proapoptotic protein compare to antiapoptotic protein. GDF9 and BMP15 protein expression'}], 'secondaryOutcomes': [{'measure': 'oocyte maturation index', 'timeFrame': '"up to 1 months"', 'description': 'fertilization rate is number of fertilized oocytes compared with all total number oocyte which taken when ovum pick-up. oocyte maturation index is the number of mature oocyte (metaphase II oocyte) compare with all total number oocyte which taken when ovum pick-up'}, {'measure': 'Fertilization rate', 'timeFrame': '"up to 1 months"', 'description': 'fertilization rate is number of fertilized oocytes compared with all total number oocyte which taken when ovum pick-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acupuncture', 'in Vitro Fertilization', 'BCL2 Gene mRNA Overexpression', 'Oocyte Maturation']}, 'descriptionModule': {'briefSummary': 'Interventional studies compared electroacupuncture group versus sham electroacupuncture group to granulosa cell apoptosis index, oocyte maturation, GDF9 and BMP15 levels, and fertilization rate in in vitro fertilization program', 'detailedDescription': 'The study was conducted at the Dr.Cipto Mangunkusumo National General Hospital, Indonesia in September - November 2018.The inclusion criteria are patients who underwent controlled ovarian stimulation with antagonist protocol, age 30-39 years, BMI \\<29kg / m2. Exclusion criteria were not having a skin infection at acupuncture point and not using a pacemaker. Then patients were randomly divided into two groups: electroacupuncture and sham electroacupuncture. Electroacupuncture therapy was done 6 times at: 2 times before and 4 times during controlled ovarian stimulation.Apoptotic index of granulosa cells were examined by quantitative real time PCR techniques for BAX/BCL-2 expression.Oocyte maturation and fertilization rate output parameters are examined by competent embryologists after ovum pick up while GDF9 and BMP15 levels were examined by quantitative real time PCR techniques for GDF9 and BMP15 mRNA expression'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women underwent controlled ovarian stimulation with antagonist protocol\n* BMI \\< 29 kg/m2\n* willing and sign the inform consent\n* follow the research until completed\n\nExclusion Criteria:\n\n* having skin infection at acupoint location\n* use a pacemaker'}, 'identificationModule': {'nctId': 'NCT03627533', 'briefTitle': 'The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF', 'orgStudyIdInfo': {'id': 'Medical Acupuncture'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture', 'description': 'Electroacupuncture therapy is done at the point of CV3 Zhongji, CV4 Guanyuan, and EXCA-1 Zigong with continuous wave, 2 Hz frequency for 30 minutes. Acupuncture manuals on MA-IC3 endocrine (ear points), GV20 Baihui, ST36 Zusanli, SP6 Sanyinjiao, BL57 Chengsan and KI3 Taixi for 30 minutes.', 'interventionNames': ['Procedure: Electroacupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham electroacupuncture', 'description': 'Sham electroacupuncture are done at same electroacupuncture point location but puncture are not done, also electro stimulator are turned off.', 'interventionNames': ['Procedure: Electroacupuncture']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'description': 'Electroacupuncture therapy is done at the point of CV3 Zhongji, CV4 Guanyuan, and EXCA-1 Zigong with continuous wave, 2 Hz frequency for 30 minutes. Acupuncture manuals on endocrine ear points, GV20 Baihui, ST36 Zusanli, SP6 Sanyinjiao, BL57 Chengsan and KI3 Taixi for 30 minutes.', 'armGroupLabels': ['Electroacupuncture', 'Sham electroacupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Indonesian University', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Christina Simadibrata, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Acupuncture of Indonesian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'nadia oktari', 'investigatorAffiliation': 'Indonesia University'}}}}