Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-31 @ 7:22 AM
Study NCT ID:
NCT01364935
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.', 'detailedDescription': 'The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female participants trying to conceive, with regular menstrual cycles.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation\n* Females aged 18 to 44 years\n* Have a body mass index (BMI) above 19 and below 29\n* Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months\n* Minimum menstrual cycle 24 days\n* Maximum menstrual cycle 33 days\n* Female participants willing to use the 3 fertility monitors for at least 3 cycles.\n* Willing to fill in regular questionnaires and study diaries\n\nExclusion Criteria:\n\n* Women aged younger than 18 years, or older than 44 years\n* Have a BMI less than 18 or greater than 29\n* Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases\n* Polycystic ovary disease\n* Endometriosis or other pelvic pathology (including proven tubal disease)\n* Taking steroids, including oral contraceptives or anti inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT01364935', 'briefTitle': 'Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors', 'nctIdAliases': ['NCT01343199'], 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application', 'orgStudyIdInfo': {'id': 'A092165'}, 'secondaryIdInfos': [{'id': '11/EE/0016', 'type': 'OTHER', 'domain': 'National Research Ethics Committee'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Basil Matta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cambridge Temperature Concepts', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN', 'investigatorFullName': 'Joanne Outtrim', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}