Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT04393857
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2020-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Vaginal, Cervical and endometrial samples taken with the Eswab (Copan), eNAT (Copan) and Tao brush (Cook medical). Although there will be Human DNA in samples, we aim to isolate bacterial DNA for further analysis. No analyses are planned on Human DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ascending infection/sharing of bacteria in the genital tract', 'timeFrame': 'This outcome data is measured at the 1 day of oocyte retrieval.', 'description': 'vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.'}], 'secondaryOutcomes': [{'measure': 'Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances', 'timeFrame': 'This outcome data is measured at the 1 day of oocyte retrieval.', 'description': 'qPCR to assess the microbiota. I.e. a quantitative measure Copies/mL. 16S V4 to investigate relative abundances'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Vaginoses']}, 'descriptionModule': {'briefSummary': 'The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy oocyte donors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOocyte donors meeting local criteria for donation. Written informed consent. Regular cycle\n\nExclusion Criteria:\n\nAntibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.\n\nAny uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)'}, 'identificationModule': {'nctId': 'NCT04393857', 'briefTitle': 'The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Viborg, Skive'}, 'officialTitle': 'The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors', 'orgStudyIdInfo': {'id': 'Microbiome_endometrial_spain'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oocyte donors', 'description': 'Healthy Oocyte donors fulfilling the criteria for oocyte donation are eligible. Patients may not have received any antibiotics or vaginal products (other than for menstrual hygiene - such as tampons) for the last 1 month. Informed consent is mandatory.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alicante', 'country': 'Spain', 'facility': 'Instituto Bernabeu', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'WE plan to share all information allowed as per national law.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Humaidan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Bernabeu', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Consultant', 'investigatorFullName': 'Peter Humaidan', 'investigatorAffiliation': 'Regionshospitalet Viborg, Skive'}}}}