Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-03 @ 6:52 PM
Study NCT ID:
NCT03064061
Status:
UNKNOWN
Last Update Posted:
2018-03-22
First Post:
2016-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2016-12-26', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of the virtual reality on the pregnancy rate (Ultrasound)', 'timeFrame': '12 weeks', 'description': 'measured by ultrasound'}], 'secondaryOutcomes': [{'measure': 'impact of the virtual reality on anxiety (numeric scale)', 'timeFrame': 'immediate', 'description': 'measured with numeric scale (0-10) before and after the VR'}, {'measure': 'impact of the virtual reality on satisfaction', 'timeFrame': 'immediate', 'description': 'measured by a numeric scale 0-10'}, {'measure': 'impact of the virtual reality on pregnancy test', 'timeFrame': '6 weeks', 'description': 'measured by blood beta HCG level'}, {'measure': 'state-trait Anxiety Inventory', 'timeFrame': 'immediate', 'description': 'measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'in Vitro Fertilization', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.\n* Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)\n\nExclusion Criteria:\n\n* Patients with long-term psychotherapeutic treatment\n* Patients taking psychotropic drugs\n* patient blind and deaf'}, 'identificationModule': {'nctId': 'NCT03064061', 'briefTitle': 'Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate', 'orgStudyIdInfo': {'id': '2016/20JUL/346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Virtual Reality Neutral', 'description': 'neutral VR session before oocytes retrieval', 'interventionNames': ['Device: Virtual reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual reality Anxiety', 'description': 'VR session with the goal of reducing anxiety before oocytes retrieval', 'interventionNames': ['Device: Virtual reality']}], 'interventions': [{'name': 'Virtual reality', 'type': 'DEVICE', 'description': 'a device with virtual reality is given to the patients with a film of 18 minutes', 'armGroupLabels': ['Virtual Reality Neutral', 'Virtual reality Anxiety']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Fabienne Roelants, MD', 'role': 'CONTACT', 'email': 'fabienne.roelants@uclouvain.be', 'phone': '+3227641821'}, {'name': 'Célilne Pirard, MD PhD', 'role': 'CONTACT', 'email': 'celine.pirard@uclouvain.be', 'phone': '+3227644112'}], 'facility': 'Cliniques universitaires Saint-luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Roelants', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}