Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-26 @ 3:17 PM
Study NCT ID:
NCT06096766
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between Ovarian Function and Serum Biomarkers
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'copper', 'timeFrame': 'On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)', 'description': 'the level of copper in blood sample'}, {'measure': 'Iron ion', 'timeFrame': 'On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)', 'description': 'the level of Iron ion in blood sample'}, {'measure': 'ceruloplasmin, CP', 'timeFrame': 'On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)', 'description': 'the level of ceruloplasmin in blood sample'}, {'measure': 'CuZn-Superoxide Dismutase, CuZn-SOD/SOD1', 'timeFrame': 'On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)', 'description': 'the level of CuZn-SOD/SOD1 in blood sample'}, {'measure': 'Malondialdehyde，MDA', 'timeFrame': 'On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)', 'description': 'the level of MDA in blood sample'}], 'secondaryOutcomes': [{'measure': 'other relative biomarkers about copper/iron metabolism and oxidative stress', 'timeFrame': 'On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)', 'description': 'depending on the results of the five biomarkers above'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Ovarian Insufficiency', 'Diminished Ovarian Reserve', 'Biomarker', 'Copper', 'Ceruloplasmin', 'Aging']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.', 'detailedDescription': 'Collect the serum of the observation group and control group volunteers, and measure the levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. in the serum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Visited the gynecology clinic of Dongzhimen Hospital from November 2023 to October 2024. Upon examination of sexual hormones or AMH, it was considered that patients with Diminished Ovarian Reserve (DOR), premature ovarian insufficiency (POI), and healthy individuals had decreased ovarian reserve function.', 'genderDescription': 'biological sex', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The selection criteria for healthy individuals are follows.\n\n * women aged 18-45.\n\n * Basic FSH\\<10IU/L, and AMH is within the normal range.\n\n * Regular menstruation.\n\n * Agree and sign an informed consent form.\n2. The selection criteria for DOR patients are follows.\n\n * women aged 18-45.\n\n * For two consecutive menstrual cycles, 25 ≥ basal FSH ≥ 10IU/L or AMH\\<1.1ng/ml.\n\n * Agree and sign an informed consent form.\n3. Selection criteria for POI patients are follows.\n\n * 18 ≤ females aged \\<40 years old.\n\n * Two consecutive menstrual cycles with basal FSH\\>25IU/L or AMH\\<1.1ng/ml.\n\n * Agree and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".\n2. Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.\n3. Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.\n4. Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.\n5. Patients during lactation or pregnancy.\n6. Patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional Chinese medicine.\n\nThose who meet any of the above 5 criteria for DOR and POI will be excluded and not included in this study. The exclusion criteria for healthy subjects are as (1), (3), (4), and (5).'}, 'identificationModule': {'nctId': 'NCT06096766', 'briefTitle': 'The Correlation Between Ovarian Function and Serum Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Dongzhimen Hospital, Beijing'}, 'officialTitle': 'Study on the Correlation Between Ovarian Function and Serum Biomarkers', 'orgStudyIdInfo': {'id': '2023DZMEC-489'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diminished Ovarian Reserve Group', 'description': 'women with DOR', 'interventionNames': ['Diagnostic Test: blood test']}, {'label': 'Premature Ovarian Insufficiency Group (POI)', 'description': 'women with premature ovarian insufficiency', 'interventionNames': ['Diagnostic Test: blood test']}, {'label': 'Control Group', 'description': 'women with normal menstruation and levels of sex hormones', 'interventionNames': ['Diagnostic Test: blood test']}], 'interventions': [{'name': 'blood test', 'type': 'DIAGNOSTIC_TEST', 'description': "Detection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection.", 'armGroupLabels': ['Control Group', 'Diminished Ovarian Reserve Group', 'Premature Ovarian Insufficiency Group (POI)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueting Han', 'role': 'CONTACT', 'email': 'dzmyyec@126.com', 'phone': '+861084012709'}, {'name': 'Yun Shi, phD', 'role': 'CONTACT'}, {'name': 'Ke Xu, Master', 'role': 'CONTACT'}], 'facility': 'Dongzhimen Hospital, Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yun Shi, PhD', 'role': 'CONTACT', 'email': 'zysyun@163.com', 'phone': '13717926522'}, {'name': 'Ke Xu, Master', 'role': 'CONTACT', 'email': '18610680372@163.com', 'phone': '18610680372'}], 'overallOfficials': [{'name': 'Yun Shi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine'}, {'name': 'Ke Xu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine'}, {'name': 'Jing Y Shao, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine'}, {'name': 'Xuan kai Cai, Master', 'role': 'STUDY_CHAIR', 'affiliation': "Shenzhen Bao'an Authentic TCM Therapy Hospital"}, {'name': 'Qin Y Liu, Bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine'}, {'name': 'Xi Y Li, Bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine'}, {'name': 'Fei Yan, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Dongzhimen Hospital of Beijing University of Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shi Yun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Shi Yun', 'investigatorAffiliation': 'Dongzhimen Hospital, Beijing'}}}}