Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-27 @ 8:37 AM
Study NCT ID:
NCT01084304
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-04-07', 'unreleaseDateUnknown': True}, {'resetDate': '2017-07-03', 'releaseDate': '2017-04-18'}, {'resetDate': '2018-10-29', 'releaseDate': '2018-02-14'}], 'estimatedResultsFirstSubmitDate': '2017-04-07'}}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol Measurement', 'timeFrame': 'Twice monthly', 'description': 'Measurement of Urinary Cortisol throughout menstrual cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Ovulation tests', 'stress', 'Wishing to become pregnant'], 'conditions': ['Stress']}, 'referencesModule': {'references': [{'pmid': '26689590', 'type': 'DERIVED', 'citation': "Jones G, Carlton J, Weddell S, Johnson S, Ledger WL. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health. 2015 Dec 21;12:116. doi: 10.1186/s12978-015-0103-y."}, {'pmid': '23081872', 'type': 'DERIVED', 'citation': 'Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.\n\nA sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with \\<5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Females aged 18 to 40 wishing to become pregnant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent to participate in the study and agree to comply with study procedures.\n* Has menstrual bleeds.\n* Seeking to become pregnant.\n* Living in UK\n\nExclusion Criteria:\n\n* Used hormonal contraception within the last 3 months.\n* Currently undergoing fertility treatment or investigation.\n* Diagnosed as infertile following investigations.\n* Drug or alcohol dependency.\n* history of depression, anxiety or panic attacks'}, 'identificationModule': {'nctId': 'NCT01084304', 'briefTitle': 'Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPD Development Company Limited'}, 'officialTitle': 'Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive', 'orgStudyIdInfo': {'id': 'PROTOCOL-0172'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active', 'description': 'Use of ovulation tests to aid conception'}, {'label': 'Control', 'description': 'No ovulation tests to aid conception'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK44 3UP', 'city': 'Bedford', 'state': 'Bedfordshire', 'country': 'United Kingdom', 'facility': 'SPD Development Company Ltd', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}], 'overallOfficials': [{'name': 'Sarah Johnson, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPD Development Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-07', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-04-18', 'type': 'RELEASE'}, {'date': '2017-07-03', 'type': 'RESET'}, {'date': '2018-02-14', 'type': 'RELEASE'}, {'date': '2018-10-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'SPD Development Company Limited'}}}}