Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-29 @ 10:07 AM
Study NCT ID:
NCT03474120
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2018-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Genetic Study in Patients With Ovarian Insufficiency
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Collect 5 ml whole blood(in EDTA anticoagulant tube) and sign an informed consent form for patients diagnosed with POI/DOR/ovarian dysgenesis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2023-12-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genotype', 'timeFrame': '1/4/2018-24/12/2020', 'description': 'Measure the genotype by genome-wide sequencing of exomes(WES) in subjects.'}], 'secondaryOutcomes': [{'measure': 'Dimensions of uterus', 'timeFrame': '1/4/2018-24/12/2020', 'description': 'Measure the vertical diameter，transverse diameter and anteroposterior diameter of uterus in millimeters'}, {'measure': 'Antral follicle count', 'timeFrame': '1/4/2018-24/12/2020', 'description': 'Measure the basic antral follicle count before controlled ovarian hyperstimulation.'}, {'measure': 'Endometrial thickness', 'timeFrame': '1/4/2018-24/12/2020', 'description': 'Measure endometrial thickness of subjects in millimeters.'}, {'measure': 'Live birth rate', 'timeFrame': '1/4/2018-24/12/2020', 'description': 'Record the live birth rate of offspring in in both groups.'}, {'measure': 'Neonatal weight', 'timeFrame': '1/4/2018-24/12/2020', 'description': 'Record the neonatal weight(in kilogram) of offspring in two groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetic causes', 'etiology', 'POI', 'DOR'], 'conditions': ['Premature Ovarian Failure', 'Primary Ovarian Insufficiency', 'Ovarian Dysgenesis', 'Diminished Ovarian Reserve']}, 'descriptionModule': {'briefSummary': 'genetic screening and etiological analysis was conducted on patients with ovarian insufficiency and decline in ovarian reserve. All patients were enrolled in the IVF-treated and non-IVF-treated groups, followed up for long-term treatment outcomes and genomic screening.', 'detailedDescription': 'The cause of ovarian insufficiency and decline in ovarian reserve are not clear, but most researchers think the probable causes are mainly three aspects: chromosomal abnormalities, genetic factors and autoimmune diseases，But the majority of patients with normal chromosome karyotype analysis. The screening of pathogenic genes in patients with normal karyotype is the focus of current premature ovarian insufficiency(POI) and decline in ovarian reserve(DOR) etiology, to further explain the pathogenesis of patients, improve the diagnosis of those diseases and Clinical treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who come to the First Affiliated Hospital of Anhui Medical University Reproductive Center and diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"，Understand the content of the project and sign an informed consent form', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as "premature ovarian insufficiency", "diminished ovarian reserve", "primary amenorrhea", " ovarian dysgenesis", " repeated implantation failure"\n\nExclusion Criteria:\n\n* To rule out polycystic ovary syndrome（PCOS）, iatrogenic factors (such as surgery, radiotherapy and chemotherapy, etc.) lead to premature ovarian insufficiency in patients'}, 'identificationModule': {'nctId': 'NCT03474120', 'briefTitle': 'Prospective Genetic Study in Patients With Ovarian Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Anhui Medical University'}, 'officialTitle': 'Prospective Genetic Study in Patients With Ovarian Insufficiency', 'orgStudyIdInfo': {'id': 'Ovarian-Gene'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVF treatment group', 'description': 'Patients treated with IVF. IVF promotion process, ovulation, fertilization, embryo quality, transplantation and final outcome were collected after the treatment cycle was completed.', 'interventionNames': ['Procedure: IVF treatment']}, {'label': 'No IVF treatment group', 'description': 'the patients who did not have received IVF treatment .Patients were followed up to collect hormone levels, ultrasound results.'}], 'interventions': [{'name': 'IVF treatment', 'type': 'PROCEDURE', 'otherNames': ['No IVF treatment'], 'description': 'Relationship between IVF treatment outcome and genotypes in POI//DOR/ovarian dysgenesis patients', 'armGroupLabels': ['IVF treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230032', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiran Zhou, MD', 'role': 'CONTACT', 'email': 'zhouyiran0309@163.com', 'phone': '+8613605690313'}, {'name': 'Bingbing Wang, Ph.D', 'role': 'CONTACT', 'email': 'wbbahu@163.com', 'phone': '+13552883407'}], 'facility': 'Reproductive Medicine Center, the First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Yiran Zhou, bachelor', 'role': 'CONTACT', 'email': 'zhouyiran0309@163.com', 'phone': '+86 13605690313'}, {'name': 'Binbin Wang, PhD', 'role': 'CONTACT', 'email': 'wbbahu@163.com', 'phone': '+86 13552883407'}], 'overallOfficials': [{'name': 'Yunxia Cao, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Reproductive Medicine Center, the First Affiliated Hospital of AMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Institute for Family Planning, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}