Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT02229604
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2014-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture for Diminished Ovarian Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D020249', 'term': 'Hormone Replacement Therapy'}, {'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of FSH from baseline', 'timeFrame': 'baseline, week 12', 'description': 'The follicle-stimulating hormone (FSH) will be tested at baseline and week 12'}], 'secondaryOutcomes': [{'measure': 'change of FSH level from baseline', 'timeFrame': 'baseline, week 4, 8, 16, 20, and 24', 'description': 'FSH will be tested at baseline and week 4, 8, 16, 20, and 24'}, {'measure': 'changes in FSH/LH ratio, LH, and E2 from baseline', 'timeFrame': 'baseline, week 4, 8, 12, 16, 20, and 24', 'description': 'FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24'}, {'measure': 'change of symptom scale', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Symptoms need to be assessed include irritability and depression. A 4-point scale is used to evaluate the degree of symptoms (0 means "not at all" and 3 means "severe").'}, {'measure': 'proportion of patients regaining regular menses', 'timeFrame': 'baseline, weeks 8, 12 and 24', 'description': 'The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['electroacupuncture', 'diminished ovarian reserve', 'cohort study'], 'conditions': ['Irregular Menses']}, 'referencesModule': {'references': [{'pmid': '27177929', 'type': 'DERIVED', 'citation': 'Wang Y, Li Y, Chen R, Cui X, Yu J, Liu Z. Electroacupuncture for reproductive hormone levels in patients with diminished ovarian reserve: a prospective observational study. Acupunct Med. 2016 Oct;34(5):386-391. doi: 10.1136/acupmed-2015-011014. Epub 2016 May 13.'}]}, 'descriptionModule': {'briefSummary': 'Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH) and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect of EA versus other therapies for DOR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age younger than 40 yr\n* 10IU/L ≤ FSH ≤ 40IU/L\n* Volunteer to join the research and give the informed consent\n\nExclusion Criteria:\n\n* A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation\n* Reproductive system infection or tumor\n* Autoimmune disease\n* Amenorrhea due to reproduction abnormality or pregnancy\n* Patients can not adhere to treatment due to personal situation\n* Patients have taken immunosuppressive agents in past 6 months\n* receive treatment for less than 1 week before withdrawal'}, 'identificationModule': {'nctId': 'NCT02229604', 'briefTitle': 'Electroacupuncture for Diminished Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study', 'orgStudyIdInfo': {'id': 'ZZ0708081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EA group', 'description': 'Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all).', 'interventionNames': ['Other: EA', 'Drug: HRT, DHEA and herb']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'drug group', 'description': 'Hormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed.', 'interventionNames': ['Drug: HRT, DHEA and herb']}], 'interventions': [{'name': 'EA', 'type': 'OTHER', 'otherNames': ['acupuncture'], 'description': 'For BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA.', 'armGroupLabels': ['EA group']}, {'name': 'HRT, DHEA and herb', 'type': 'DRUG', 'description': 'HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).', 'armGroupLabels': ['EA group', 'drug group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhishun Liu, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': "Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Dean of Acupuncture Department of Guangan'men Hospital", 'investigatorFullName': 'Liu Zhishun', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}