Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-04 @ 4:54 PM
Study NCT ID:
NCT03208595
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2017-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Flora in Women Undergoing IVF Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bacterial DNA only'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-03', 'studyFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess endometrial caracteristicas in fertile and infertile women using next generation sequencing of bacterial identification', 'timeFrame': '2017-2020', 'description': 'Type of flora identified by next generation sequencing of bacterial identification'}, {'measure': 'To identify specific endometrial flora in association to faliure of IVF treatment', 'timeFrame': '2017-2020', 'description': 'Type of flora identified by NGS'}, {'measure': 'to assess the feasibility of endometrial sampling in women undergoing embryo transfer by a standart transfer cateteher', 'timeFrame': '2017-2020', 'description': 'Mode of endometrial sampling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Flora Characterization in Infertile Women']}, 'descriptionModule': {'briefSummary': 'Characterization of the female genital tract microbiome in women undergoing IVF treatment', 'detailedDescription': 'The primary goal With The purpose of our study is to examine the uterine microbiome by Next-generation sequencing of the bacteria specific regions .\n\nVaginal and uterine swabs will be taken in different women undergoing IVF /PGD. Novel bacteria and results of taxonomy assignments will be examine to find correlation of uterine flora with IVF and obstetrical outcomes.\n\nThe metagenomics approach will be used to seek previously unidentified bacterial species in the human upper genital tract.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing transfer of a single euploid blastocyst .The specimen will be obtaine from the embryo transfer catheter.', 'genderDescription': 'All infertile women', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All undergoning IVF treatment\n* Embryo transfer of one Blastocyst\n\nExclusion Criteria:\n\n* More then one Embryo Transfer\n* Recent antibacterial treatment'}, 'identificationModule': {'nctId': 'NCT03208595', 'briefTitle': 'Endometrial Flora in Women Undergoing IVF Treatments', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Endometrial Flora Sampling in Women Undergoing IVF/PGD Treatments', 'orgStudyIdInfo': {'id': '0201-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endometrial sampling of a Typical Embryo transfer catheter', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['no intervention'], 'description': 'no intervention no additional change from unit protocol'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director General for R&D', 'investigatorFullName': 'michal roll', 'investigatorAffiliation': 'Tel-Aviv Sourasky Medical Center'}}}}