Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-09 @ 1:53 PM
Study NCT ID:
NCT03134651
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Anxiety at Oocyte Retrieval
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D058926', 'term': 'Intraoperative Awareness'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in perioperative Monitoring brain function were measured', 'timeFrame': 'Preoperative, intraoperative and postoperative first minute', 'description': 'Monitoring brain function was assessed Change from baseline at preoperatively, intraoperative 5th and 15th minutes and after anesthesia'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '10 days', 'description': 'pregnancy rate'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Oocyte retrieval', 'Monitoring of brain function'], 'conditions': ['Infertility, Female', 'Anesthesia Awareness', 'Anxiety State']}, 'descriptionModule': {'briefSummary': "This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score: a low-anxiety group, while the other half high-anxiety group.", 'detailedDescription': 'Anxiety is common among women hospitalized for oocyte retrieval. Infertility is usually accompanied by psychological and behavioral changes and can result in preoperative anxiety. Sometimes, preoperative anxiety can be serious. Furthermore, in the absence of premedication for oocyte retrieval, severe degrees of anxiety may occur. Anxiety effects the total consumption of analgesic and anesthetic drugs intraoperatively and has a negative impact on recovery from anesthesia. In addition, the negative effect of anesthetic agents used on fertilization and embryo quality during in vitro fertilization (IVF) has been discussed. However, the impact of any of them on fertilization and embryo quality has not been clearly determined to date. Studies have reported different results regarding the negative effects of anesthetic agents on embryo development and fertilization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'infertile women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oocyte retrieval under sedation\n* 25 and 43 years of age\n* American Society of Anesthesiologists physical status I-II\n\nExclusion Criteria:\n\n* history of psychiatric illness\n* secondary infertility can be surgically corrected\n* not able to communicate well in the native language\n* those women who necessitated general anesthesia'}, 'identificationModule': {'nctId': 'NCT03134651', 'briefTitle': 'Preoperative Anxiety at Oocyte Retrieval', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'The Effect of Preoperative Anxiety With Depth of Anesthesia During Oocyte Retrieval on IVF Success', 'orgStudyIdInfo': {'id': 'TUTF-GOKAEK 2014/115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Monitoring brain function-low-anxiety', 'description': 'Anxiety has determined a cutoff score of 17. Patients were divided into two groups according to the recorded BAI score: a low-anxiety group and a high-anxiety group.The monitoring brain function values were recorded at baseline, 5 minutes, 15 minutes, and after anesthesia. Propofol was performed by ventilation with face mask. Monitoring brain function was keep value between 40 and 60.', 'interventionNames': ['Device: Monitoring brain function', 'Drug: propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'monitoring brain function-high-anxiety', 'description': 'Anxiety has determined a cutoff score of 17. Patients were divided into two groups according to the recorded BAI score: a low-anxiety group and a high-anxiety group.The monitoring brain function values were recorded at baseline, 5 minutes, 15 minutes, and after anesthesia. Propofol was performed by ventilation with face mask. Monitoring brain function was keep value between 40 and 60.', 'interventionNames': ['Device: Monitoring brain function', 'Drug: propofol']}], 'interventions': [{'name': 'Monitoring brain function', 'type': 'DEVICE', 'armGroupLabels': ['Monitoring brain function-low-anxiety', 'monitoring brain function-high-anxiety']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['propofol %1'], 'armGroupLabels': ['Monitoring brain function-low-anxiety', 'monitoring brain function-high-anxiety']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sevtap Hekimoglu Sahin, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Trakya University Medical Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Sevtap Hekimoglu Sahin', 'investigatorAffiliation': 'Trakya University'}}}}