Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT00921492
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study.', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Ovulation, health related quality of life', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Luteinizing hormone', 'Cortisol', 'HPA axis', 'HPO axis', 'Ovulation', 'Heart rate variability', 'Psychological distress and quality of life'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '23482444', 'type': 'DERIVED', 'citation': 'Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis The overall hypothesis is that non-obese (BMI \\<30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.', 'detailedDescription': 'Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.\n\nAim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.\n\nAim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 39 years, inclusive\n* 30 ≤ BMI\n* History of irregular menstrual cycles\n* Clinical and/or biochemical androgen excess (determined during screening)\n\nExclusion Criteria:\n\nMedical Exclusion Criteria\n\n* History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.\n* Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.\n\nPsychiatric and Behavioral Exclusion Criteria\n\n* Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT00921492', 'acronym': 'PCOSLFEA', 'briefTitle': 'Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'PCOSLFEA-17611'}, 'secondaryIdInfos': [{'id': '2008-72VP-15445-01A'}, {'id': 'ALFFGBG-10984'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-frequency electro-acupuncture', 'interventionNames': ['Device: Low-frequency electro-acupuncture (EA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meeting a therapist - attention', 'interventionNames': ['Other: Meeting a therapist - attention control']}], 'interventions': [{'name': 'Low-frequency electro-acupuncture (EA)', 'type': 'DEVICE', 'description': '2 Hz EA during 30 minutes, twice a week, 14 weeks.', 'armGroupLabels': ['Low-frequency electro-acupuncture']}, {'name': 'Meeting a therapist - attention control', 'type': 'OTHER', 'description': 'Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.', 'armGroupLabels': ['Meeting a therapist - attention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40530', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}