Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-28 @ 6:38 AM
Study NCT ID:
NCT03420859
Status:
UNKNOWN
Last Update Posted:
2023-04-27
First Post:
2018-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Vaginal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1850}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2018-01-01', 'studyFirstSubmitQcDate': '2018-01-28', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal vaginal microbiota', 'timeFrame': 'minimum 2-7 days from vaginal swab.', 'description': 'qPCR positive diagnosis as described in intervention.'}], 'secondaryOutcomes': [{'measure': 'Intimate hygiene', 'timeFrame': '2-5 weeks from baseline to embryo transfer', 'description': 'questionnaire'}, {'measure': 'Male/partner seminal microbiome', 'timeFrame': '2-4 weeks from baseline to oocyte pick-up', 'description': 'DNA sequencing of seminal samples'}, {'measure': 'Number of participants with Clinical pregnancy as measured by heartbeat', 'timeFrame': '7-9 weeks after inclusion.', 'description': 'Tested by ultrasound scanning in week 7-9.'}, {'measure': 'Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks)', 'timeFrame': '36-42 weeks after inclusion', 'description': 'Tested by self-reported schemes mailed to the clinics.'}, {'measure': 'Cumulative live birth rate', 'timeFrame': '9 months - 24 months after inclusion', 'description': 'The number of live births originating from one controlled ovarian stimulation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abnormal Vaginal Microbiota', 'Infertility']}, 'descriptionModule': {'briefSummary': 'A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.', 'detailedDescription': 'At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile women fulfilling the abovementioned criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First, second or third IVF stimulation cycle at the involved clinic.\n* BMI\\<35.\n* Written informed consent.\n* 18-42 years old\n\nExclusion Criteria:\n\n* HIV, Hepatitis B or C positivity.\n* Intrauterine malformations (Vaginal ultrasound)\n* Hysterosalpinx\n* Known severe renal or hepatic impairment.\n* HPV CIN 2 or higher.\n* Patients treated with vitamin K antagonists (warfarin)\n* Known or suspected hypersensitivity to clindamycin or any other antibiotic.\n* Myastenia Gravis\n* Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa\n* Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)'}, 'identificationModule': {'nctId': 'NCT03420859', 'briefTitle': 'The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Viborg, Skive'}, 'officialTitle': 'The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes', 'orgStudyIdInfo': {'id': '1-16-02-404-16 (datatilsynet)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'qPCR for abnormal vaginal microbiota', 'type': 'DIAGNOSTIC_TEST', 'description': 'qPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Skive', 'country': 'Denmark', 'facility': 'Fertility Clinic Skive, Skive Regional Hospital', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}], 'overallOfficials': [{'name': 'Peter Humaidan, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Fertility Clinic Skive'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'By Danish law, we cannot share individual data. But pseudomized data might be available from the National Danish archives. We aim to publish as fully as possible by Danish data protection law.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Humaidan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Statens Serum Institut', 'class': 'OTHER'}, {'name': 'Stork Fertility Clinic, VivaNeo, Copenhagen', 'class': 'UNKNOWN'}, {'name': 'Hvidovre Fertility Clinic, Copenhagen', 'class': 'UNKNOWN'}, {'name': 'Køge Fertility Clinic, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Consultant', 'investigatorFullName': 'Peter Humaidan', 'investigatorAffiliation': 'Regionshospitalet Viborg, Skive'}}}}