Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-28 @ 1:26 PM
Study NCT ID:
NCT07041632
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Relief in Women Undergoing Oocyte Retrieval (OR) With Electro-acupuncture (EA) or Conscious Sedation (CS) in a Single Assisted Reproduction Centre.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016292', 'term': 'Conscious Sedation'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomised control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief during egg collection', 'timeFrame': 'from start of egg collection. to 120 minutes after egg collection', 'description': 'Pain score 1 to 10 during egg collection in IVF compared between using acupuncture and conscious sedation'}], 'secondaryOutcomes': [{'measure': 'Stress, satisfaction measurement and physical parameters between acupuncture and conscious sedation during egg collection in IVF', 'timeFrame': 'Up to 120 minutes after egg collection', 'description': 'Stress score and satisfaction outcome scores 0 to 10 for pain relief between acupuncture and conscious sedation during egg collection were recorded. For the stress score, zero is equivalent to no stress and 10 indicates the worst possible stress. For the satisfaction score, zero is equivalent to no satisfaction at all and 10 is the highest satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture, oocyte retrieval, sedation'], 'conditions': ['Pain Intensity Assessment']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether one can replace pain relief in women undergoing oocyte retrieval (OR) using electro-acupuncture (EA) instead of conscious sedation (CS).', 'detailedDescription': 'A total of 60 women were randomized and 29 women were on electro-acupuncture (EA) versus 27 women on conscious sedation (CS) with intravenous medication for transvaginal egg extraction (OR) in IVF. Pain scores were recorded before , during and after egg extraction when the women were on conscious sedation and electro-acupuncture. Side effects were recorded. Physical parameters were recorded. Livebirth outcome were also recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'ivf female patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: all women undergoing ivf and have given consent -\n\nExclusion Criteria: women who have infectious skin diseases, women who were unwilling to accept acupunture, history of bleeding disorders.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07041632', 'acronym': 'EA', 'briefTitle': 'Pain Relief in Women Undergoing Oocyte Retrieval (OR) With Electro-acupuncture (EA) or Conscious Sedation (CS) in a Single Assisted Reproduction Centre.', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Can Acupuncture Replace Conscious Sedation in In-Vitro-Fertilization Transvginal Oocyte Retrievals?', 'orgStudyIdInfo': {'id': 'Acupuncture in IVF'}, 'secondaryIdInfos': [{'id': 'TCMCRG3103002', 'type': 'OTHER', 'domain': 'Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'electro-acupuncture', 'description': 'Electro-acupunture is compared to Conscious sedation during egg collection in IVF', 'interventionNames': ['Other: electro-acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conscious sedation for egg collection', 'description': 'Conscious sedation is the common analgesia used in egg collection in IVF', 'interventionNames': ['Other: Conscious sedation']}], 'interventions': [{'name': 'electro-acupuncture', 'type': 'OTHER', 'description': 'electro-acupuncture for pain relief in egg collection in IVF', 'armGroupLabels': ['electro-acupuncture']}, {'name': 'Conscious sedation', 'type': 'OTHER', 'description': 'IVf egg collection using conscious sedation as the usual analgesia', 'armGroupLabels': ['Conscious sedation for egg collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '165608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Centre for Assisted Reproduction', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Su Ling Yu, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study has completed a few years ago.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}