Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-01 @ 12:17 PM
Study NCT ID:
NCT01004068
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2009-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D000858', 'term': 'Anovulation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-02', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovulation rate', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'Clinical data', 'timeFrame': 'three months'}, {'measure': 'Metabolic data', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Clomiphene', 'Diet', 'Exercise', 'Infertility', 'PCOS', 'Physical activity', 'Treatment'], 'conditions': ['Polycystic Ovary Syndrome', 'Anovulation']}, 'referencesModule': {'references': [{'pmid': '17264174', 'type': 'BACKGROUND', 'citation': 'Vigorito C, Giallauria F, Palomba S, Cascella T, Manguso F, Lucci R, De Lorenzo A, Tafuri D, Lombardi G, Colao A, Orio F. Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Apr;92(4):1379-84. doi: 10.1210/jc.2006-2794. Epub 2007 Jan 30.'}, {'pmid': '18158291', 'type': 'BACKGROUND', 'citation': 'Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.'}, {'pmid': '20858697', 'type': 'RESULT', 'citation': 'Palomba S, Falbo A, Giallauria F, Russo T, Rocca M, Tolino A, Zullo F, Orio F. Six weeks of structured exercise training and hypocaloric diet increases the probability of ovulation after clomiphene citrate in overweight and obese patients with polycystic ovary syndrome: a randomized controlled trial. Hum Reprod. 2010 Nov;25(11):2783-91. doi: 10.1093/humrep/deq254. Epub 2010 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC. Structured exercise training (SET) and diet has been successfully employed to restore ovarian function and to improve reproductive outcomes in obese and overweight women with PCOS. The current study was aimed to test the hypothesis that a short-term SET program plus diet intervention can improve the ovarian response to CC in CC-resistant PCOS patients.', 'detailedDescription': 'Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of CC were randomized in three arms (group A, B, and C). Group A underwent SET program plus hypocaloric diet for two months, group B had one month of observation followed by one-cycle of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and received one-cycle of CC for one cycle. CC was always given at the maximal dose previously used. Clinical, hormonal and metabolic data were assessed at baseline and after intervention. Ovulation was monitored by ultrasound and confirmed by plasma progesterone assay.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCOS\n* Anovulation\n\nExclusion Criteria:\n\n* Major Medical Condition\n* Severe Obesity'}, 'identificationModule': {'nctId': 'NCT01004068', 'briefTitle': 'Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'Does Short-term Structured Exercise Training Program Plus Diet Intervention Improve Ovarian Sensitivity to Clomiphene Citrate in Polycystic Ovary Syndrome Patients (PCOS)? A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '06/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SET-diet plus clomiphene', 'description': 'Structured exercise program plus hypocaloric diet for two months and received one-cycle of clomiphene citrate for one cycle', 'interventionNames': ['Other: SET-diet plus clomiphene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clomiphene citrate', 'description': 'One month of observation followed by one-cycle of clomiphene citrate therapy', 'interventionNames': ['Drug: Clomiphene citrate']}, {'type': 'EXPERIMENTAL', 'label': 'SET plus diet', 'description': 'Lifestyle modifications for two months.', 'interventionNames': ['Behavioral: Structured exercise program plus hypocaloric diet']}], 'interventions': [{'name': 'SET-diet plus clomiphene', 'type': 'OTHER', 'otherNames': ['Lifestyle modification', 'CC'], 'description': 'Two months of structured exercise program plus hypocaloric diet followed by 150 mg daily of clomiphene citrate', 'armGroupLabels': ['SET-diet plus clomiphene']}, {'name': 'Clomiphene citrate', 'type': 'DRUG', 'otherNames': ['CC'], 'description': 'Clomiphene citrate at 150 mg daily for one cycle', 'armGroupLabels': ['Clomiphene citrate']}, {'name': 'Structured exercise program plus hypocaloric diet', 'type': 'BEHAVIORAL', 'otherNames': ['Lifestyle modifications'], 'description': 'SET plus diet', 'armGroupLabels': ['SET plus diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': '"Pugliese" Hospital', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'overallOfficials': [{'name': 'Stefano Palomba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Magna Graecia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Magna Graecia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Obstetrics and Gynecology', 'oldOrganization': 'University Magna Graecia of Catanzaro'}}}}