Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 4:31 AM
Study NCT ID:
NCT04438759
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2020-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain experience as assessed using visual analog scale', 'timeFrame': '1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure', 'description': "quantified through visual analog scale: from 0.0 to 10.0cm, ranging from 0.0 meaning 'No pain' and 10.0 representing 'worst imaginable pain'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'hysteroscopy', 'infertility'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'hysteroscopy requires presence of uterus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing fertility treatments\n* for which outpatient hysteroscopy has been prescribed\n* for different possible indications: suspicion of intracavitary pathology, recurrent implantation failure, recurrent early pregnancy loss, …\n\nExclusion Criteria:\n\n1. Hearing impairments and blindness\n2. Motion sickness\n3. Any known anatomical characteristics that may make performing the office procedure impossible.\n4. The unwillingness of the patient to undergo an office hysteroscopy\n5. Denial or withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT04438759', 'acronym': 'HYSVIR', 'briefTitle': 'Clinical Efficacy of Virtual Reality During Office Hysteroscopy and Endometrial Biopsy in Subfertility', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Outpatient Hysteroscopy and Endometrial Biopsy in Subfertility Patients', 'orgStudyIdInfo': {'id': 'HYSVIR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'investigational group', 'description': 'Virtual Reality', 'interventionNames': ['Device: Oncomfort, commercially available Virtual Reality headset']}, {'type': 'NO_INTERVENTION', 'label': 'reference group', 'description': 'standard of care'}], 'interventions': [{'name': 'Oncomfort, commercially available Virtual Reality headset', 'type': 'DEVICE', 'description': 'Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC', 'armGroupLabels': ['investigational group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel CRG', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'valerie schutyser', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}