Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 8:02 AM
Study NCT ID:
NCT04838535
Status:
UNKNOWN
Last Update Posted:
2021-04-09
First Post:
2021-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follicular Fluid Raman Shifts and IVF Outcomes
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2021-04-03', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between polycystic ovary syndrome and normal follicular fluids', 'timeFrame': '24 months', 'description': 'Raman spectrum was applied and the Raman spectrum characteristic absorption peak can be revealed. PCA analysis was used to measure the degree of differential shifts.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'IVF']}, 'descriptionModule': {'briefSummary': 'This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients fit the Rotterdam criteria for PCOS\n* Patients under IVF cycles\n\nExclusion Criteria:\n\n* Patients with male factors infertility\n* Patients with fallopian tube factors infertility'}, 'identificationModule': {'nctId': 'NCT04838535', 'briefTitle': 'Follicular Fluid Raman Shifts and IVF Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'ShangHai Ji Ai Genetics & IVF Institute'}, 'officialTitle': 'The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'JIAI E2019-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PCOS follicular fluid', 'interventionNames': ['Diagnostic Test: Raman spectrum']}], 'interventions': [{'name': 'Raman spectrum', 'type': 'DIAGNOSTIC_TEST', 'description': 'The wavelength of the follicular fluids were scaned by Raman spectrum', 'armGroupLabels': ['PCOS follicular fluid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Fu, Dr.', 'role': 'CONTACT', 'email': 'fujing_givf@163.com', 'phone': '63459977'}], 'facility': 'Shanghai JiAi Genetics and IVF Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoxi Sun, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai JiAi Genetics & IVF Institute'}, {'name': 'Jing Fu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai JiAi Genetics & IVF Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShangHai Ji Ai Genetics & IVF Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}