Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-30 @ 8:00 AM
Study NCT ID:
NCT05521295
Status:
UNKNOWN
Last Update Posted:
2022-09-19
First Post:
2022-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conception', 'timeFrame': '09.01.2022 to 09.01.2024', 'description': 'Concentration of serum human chorionic gonadotropin ≥10 mIU/mL'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': '09.01.2022 to 09.01.2024', 'description': 'detection of a gestational sac in the uterine cavity 3 weeks after conception'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility', 'Microbiome']}, 'descriptionModule': {'briefSummary': 'This study intends to explore the correlation between cervical microbiome, gut microbiome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending Center of Reproductive Medicine', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;\n2. Female age: 20-45 years old;\n3. Single frozen-thawed blastocyst Transferred\n4. Endometrial thickness ≥7mm on the day of luteal transformation\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease;\n2. Untreated hyperprolactinemia, thyroid disease, adrenal disease\n3. Antibiotic use within the past 7 days;\n4. Current or recent (within 3 months) drug abuse, including alcohol and tobacco;\n5. Refused or unable to comply with protocol requirements;\n6. Participation in any experimental drug study within 60 days prior to screening.'}, 'identificationModule': {'nctId': 'NCT05521295', 'briefTitle': 'Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Microbiome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Shengjing Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conception positive', 'description': 'serum human chorionic gonadotropin ≥10 mIU/mL', 'interventionNames': ['Other: no intervention']}, {'label': 'Conception negative', 'description': 'serum human chorionic gonadotropin \\<10 mIU/mL', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention in this study', 'armGroupLabels': ['Conception negative', 'Conception positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuxia Wang', 'role': 'CONTACT', 'email': 'wangxxsj@sina.cn', 'phone': '18940251898'}], 'facility': 'Xiuxia Wang', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Fangqing Zhao, Doctor', 'role': 'CONTACT', 'email': 'zhfq@biols.ac.cn', 'phone': '15210356144'}], 'overallOfficials': [{'name': 'Xiuxia Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Reproductive Medicine, Shengjing Hospital of China Medical University'}, {'name': 'Donghua Cao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengyang Jinghua Hospital Co.,Ltd'}, {'name': 'Sufen Cai, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive and Genetic Hospital of CITIC-Xiangya'}, {'name': 'Yanwen Xu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medical Center, the First Affiliated Hospital, Sun Yat-sen University'}, {'name': 'Hong Li, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of reproduction and genetics Suzhou Municipal Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Institutes of Life Science, Chinese Academy of Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiuxia Wang', 'investigatorAffiliation': 'Shengjing Hospital'}}}}