Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01116167
Status:
UNKNOWN
Last Update Posted:
2013-05-20
First Post:
2010-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D001599', 'term': 'Berberine'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001600', 'term': 'Berberine Alkaloids'}, {'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live-birth rate', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Ovulation rate', 'timeFrame': 'Up to 1 year'}, {'measure': 'Ongoing pregnancy rate at around gestation 8-10 weeks', 'timeFrame': 'Up to 1 year'}, {'measure': 'Multiple pregnancy rate', 'timeFrame': 'Up to 1 year.'}, {'measure': 'Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation', 'timeFrame': 'Up to 1 year'}, {'measure': 'Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Infant outcome', 'timeFrame': 'Up to 1 year'}, {'measure': 'Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Side effect.', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '34085287', 'type': 'DERIVED', 'citation': 'Zhou K, Zhang J, Xu L, Lim CED. Chinese herbal medicine for subfertile women with polycystic ovarian syndrome. Cochrane Database Syst Rev. 2021 Jun 4;6(6):CD007535. doi: 10.1002/14651858.CD007535.pub4.'}, {'pmid': '24282248', 'type': 'DERIVED', 'citation': 'Li Y, Kuang H, Shen W, Ma H, Zhang Y, Stener-Victorin E, Hung E, Ng Y, Liu J, Kuang H, Hou L, Wu X. Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double-blind randomised controlled trial. BMJ Open. 2013 Nov 25;3(11):e003934. doi: 10.1136/bmjopen-2013-003934.'}]}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chinese women\n* Age between 20 and 40 years.\n* Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):\n\n 1. Oligo- or anovulation\n 2. Clinical and/or biochemical signs of hyperandrogenism\n 3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)\n* At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.\n* Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.\n\nExclusion Criteria:\n\n* Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months.\n* Patients with known sever organ dysfunction or mental illness.\n* Pregnancy, post-abortion or postpartum within the past 6 weeks.\n* Breastfeeding within the last 6 months.\n* Not willing to give written consent to the study."}, 'identificationModule': {'nctId': 'NCT01116167', 'briefTitle': 'Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine', 'organization': {'class': 'OTHER', 'fullName': 'Heilongjiang University of Chinese Medicine'}, 'officialTitle': 'Letrozole and Berberine in Infertile PCOS Patients', 'orgStudyIdInfo': {'id': 'you070316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole -Berberine', 'interventionNames': ['Drug: Letrozole -Berberine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole', 'interventionNames': ['Drug: Letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Berberine', 'interventionNames': ['Drug: Berberine']}], 'interventions': [{'name': 'Letrozole -Berberine', 'type': 'DRUG', 'description': 'Letrozole\n\n2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.\n\nBerberine\n\n1.5g daily for 6 month.', 'armGroupLabels': ['Letrozole -Berberine']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole\n\n2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.\n\nBerberine Placebo\n\n5 tablet tds for 6 months', 'armGroupLabels': ['Letrozole']}, {'name': 'Berberine', 'type': 'DRUG', 'description': 'Berberine\n\n1.5g daily for 6 month.\n\nLetrozole placebo\n\n1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6.', 'armGroupLabels': ['Berberine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Anhui University of Chinese Medicine', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongxia Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou Medical School First Affiliated Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '163000', 'city': 'Daqing', 'state': 'Heilongjiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Daqing LongNa Hospital', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'city': 'Daqing', 'state': 'Heilongjiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Daqing Longnan hospital', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'zip': '150040', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoke Wu, MD.PhD.', 'role': 'CONTACT', 'email': 'xiaokewu2002@vip.sina.com', 'phone': '86-451-8213 0094'}, {'name': 'Lihui Hou, MD.', 'role': 'CONTACT', 'email': 'houlihui2007@sina.com', 'phone': '86-451-8213 0094'}, {'name': 'Lihui Hou, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaoke Wu, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Affliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Mudanjiang', 'state': 'Heilongjiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Mudanjiang maternal and children hospital', 'geoPoint': {'lat': 44.54804, 'lon': 129.62594}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': '2nd Affiliated Hospital of Henan University of Chinese Medicine', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Affiliated Hospital of Hunan University of Chinese', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Suqian', 'state': 'Jiangsu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'SuqianMaternal and Child Health Hospital', 'geoPoint': {'lat': 33.94917, 'lon': 118.29583}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Hospital, Jiangxi college of Chinese Medicine', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Dalian', 'state': 'Liaoning', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Dalian Maternal and Child Health Hospital', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Shanxi Hospital of Chinese Medicine', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'First Affiliated Hospital of Tianjin University of Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Second Affiliated Hospital, Tianjin University of Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Zhejiang province hospital of integrated traditional and western medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Harbin', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Second Affiliated Hospital of Heilongjiang University of Chinese Medicine', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Yan Li, MD.PhD.', 'role': 'CONTACT', 'email': 'liyantcm@163.com'}], 'overallOfficials': [{'name': 'Lihui Hou, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affliated Hospital,Heilongjiang University of Chinese Medicine .'}, {'name': 'Xiaoke Wu, MD.PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affliated Hospital,Heilongjiang University of Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heilongjiang University of Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology of the People´s Republic of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Department Chairman of Obstetrics and Gynecology', 'investigatorFullName': 'Xiaoke Wu', 'investigatorAffiliation': 'Heilongjiang University of Chinese Medicine'}}}}