Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02683967
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2016-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-12', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '18 months', 'description': 'The primary objective is to determine the clinical effectiveness of acupuncture in improving live birth rates in women undergoing IVF'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '18 months', 'description': 'The secondary objective is to determine whether acupuncture improves clinical pregnancy rate'}, {'measure': 'Multiple pregnancy', 'timeFrame': '9 months', 'description': 'To determine whether there is an increased rate of multiple pregnancy'}, {'measure': 'Quality of life', 'timeFrame': '9 months', 'description': 'To examine the effect of acupuncture on improving the quality of life for women by means of EQ% quality of life questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The trial aims to investigate whether acupuncture has an effect in increasing clinical pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing IVF treatment.', 'detailedDescription': 'Failing to conceive naturally poses significant stress to the infertile couple. It creates a feeling of failure and frustration. It has been found that the use of complementary therapies makes women feel empowered, with a sense of regaining control of the body.\n\nThe popularity of acupuncture is increasing. A significant proportion of couples having fertility treatment, especially IVF (In-Vitro Fertilisation) ask their clinician about using acupuncture and some patients undergo acupuncture privately without reporting to their clinicians.\n\nThe effectiveness of acupuncture on IVF has been extensively researched; however the results are varied and not conclusive. This is due to previous studies varying significantly in their study design, acupuncture timing and the final outcome measure. As a result of the difference in the studies it is not clear whether acupuncture is beneficial regarding IVF success rates and whether it should be offered to women undergoing IVF.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women under the age of 43 years with a BMI of less than 30 undergoing 1st or no more than their 2nd failed fresh IVF or ICSI cycle.\n\nExclusion Criteria:\n\n* Those women undergoing frozen embryo replacement cycle or receiving donor eggs, BMI \\> 30 or currently having acupuncture/ any other form of CAM, having contraindication to acupuncture like those with HIV, Hep C will be excluded.'}, 'identificationModule': {'nctId': 'NCT02683967', 'briefTitle': 'The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Homerton University Hospital NHS Foundation Trust'}, 'officialTitle': 'The Impact of Acupuncture on the Success Rate of IVF Treatments', 'orgStudyIdInfo': {'id': 'FE1303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture', 'description': 'These patients received acupuncture during the follicular development phase and on the day of egg collection.', 'interventionNames': ['Procedure: acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients received standard care, no acupuncture.'}], 'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE', 'description': 'patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.', 'armGroupLabels': ['Acupuncture']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karin Gillerman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Honorary Contract'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Homerton University Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}