Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-01-06 @ 8:50 PM
Study NCT ID:
NCT04202302
Status:
UNKNOWN
Last Update Posted:
2019-12-18
First Post:
2019-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2019-12-15', 'studyFirstSubmitQcDate': '2019-12-15', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '12.2019-03.2020', 'description': 'no. of clinical pregnancy / total number of embryo transfer cycles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Flora Imbalance']}, 'descriptionModule': {'briefSummary': 'Vaginal flora is closely related to female reproductive health. Previous studies have suggested that the composition of the vaginal flora is related to the pregnancy outcomes, and abnormalities in the vaginal flora lead to a decrease in the success rate of IVF. During the IVF treatment, the hormone level changes far exceed the physiological level. What changes will happen to the vaginal flora? Does IVF treatment itself affect the vaginal flora and affect outcomes? This study used prospective cohort study to show the changes in vaginal flora during conventional IVF treatment, providing more evidence for revealing the relationship between vaginal flora and infertility treatment outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is from the infertility patients of reproductive center of Sun Yat-sen Memorial Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-40 years old\n* BMI\\<30kg/m2\n* First IVF/ICSI cycle (GnRH agonist or antagonist protocol)\n* no vaginitis after recruitment\n* completion of oocyte retrieval\n\nExclusion Criteria\n\n* history of RSA\n* history of endometriosis\n* Immune diseases such as SLE, etc., and the use of immunosuppressive agents, glucocorticoids, etc.\n* obvious hydrosalpinx(\\>2cm in diameter by ultrasound)'}, 'identificationModule': {'nctId': 'NCT04202302', 'briefTitle': 'Vaginal Profile in IVF/ICSI and Impact on Clincal Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'The Impact of Vaginal Profile During Ovarian Stimulation on the IVF/ICSI Outcome: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'SYSEC-KY-KS-2019-161'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IVF/ICSI', 'type': 'PROCEDURE', 'description': 'ovarian stimulation ，vaginal disinfection of flushing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiyan Lin, Doctor', 'role': 'CONTACT', 'email': 'linhaiyan_818@163.com', 'phone': '8602081332233'}], 'facility': 'Reproductive center of Sun Yat-sen memorial hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Haiyan Lin, Doctor', 'role': 'CONTACT', 'email': 'linhaiyan_818@163.com', 'phone': '8602081332233'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Haiyan Lin', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}