Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03518918
Status:
UNKNOWN
Last Update Posted:
2018-05-08
First Post:
2017-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of serum FSH levels', 'timeFrame': 'through study completion, an average of 3 months, assessed up to 48 months', 'description': 'the serum FSH levels between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level \\>25mIU/mL, whichever came first.'}, {'measure': 'Menstruation situation', 'timeFrame': 'through study completion, an average of 3 months, assessed up to 48 months', 'description': 'the length of the menstrual cycle from date of recruit until the date of study completion or date of twice FSH level \\>25mIU/mL, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Change of Antral follicle count', 'timeFrame': 'through study completion, an average of 3 months, assessed up to 48 months', 'description': 'the Antral follicle count between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level \\>25mIU/mL, whichever came first.'}, {'measure': 'Change of anti-mullerian hormone levels', 'timeFrame': 'through study completion, an average of 3 months, assessed up to 48 months', 'description': 'the anti-mullerian hormone between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level \\>25mIU/mL, whichever came first.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature ovarian insufficiency', 'Diagnosis standard', 'Risk factors'], 'conditions': ['Primary Ovarian Insufficiency']}, 'descriptionModule': {'briefSummary': 'The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.', 'detailedDescription': 'Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level \\>25 mIU/mL on two occasion \\>4 weeks apart. But there still no diagnosis standard of POI in Chinese.The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female under the condition of diminished ovarian reserve were enrolled in the study. The condition of diminished ovarian reserve may be the early stage of premature ovarian insufficiency.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertility\n* The length of menstrual cycle longer than 35 days or shorter than/amenorrhea\n* Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two occasion \\>4 weeks apart\n\nExclusion Criteria:\n\n* Polycystic Ovarian Syndrome\n* other causes of amenorrhea'}, 'identificationModule': {'nctId': 'NCT03518918', 'briefTitle': 'Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study', 'orgStudyIdInfo': {'id': 'NFEC-2016-141'}}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi-Ling Chen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'chensl_92@163.com', 'phone': '+86-20-62787604'}, {'name': 'Shi-Ling Chen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shi-ling Chen, M.D, Ph.D', 'role': 'CONTACT', 'email': 'chensl_92@163.com', 'phone': '+86-020-62787604'}], 'overallOfficials': [{'name': 'Shi-ling Chen, M.D, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Southern Medical University', 'class': 'OTHER_GOV'}, {'name': 'Shenzhen Hospital of Southern Medical University', 'class': 'OTHER'}, {'name': 'Shen-Zhen City Maternity and Child Healthcare Hospital', 'class': 'OTHER'}, {'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}