Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-30 @ 7:52 AM
Study NCT ID:
NCT05852951
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2023-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cycle and Ovulation Study Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 698}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective ovulation day estimate', 'timeFrame': '12 months', 'description': 'Retrospective ovulation day estimation (algorithm uses multiple measurements including menstrual flow, urine ovulation prediction testing, basal body temperature, overnight aggregated wrist temperature)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menstruation', 'ovulation', 'menstrual cycle'], 'conditions': ['Menstruation']}, 'referencesModule': {'references': [{'pmid': '39881571', 'type': 'DERIVED', 'citation': 'Wang Y, Park J, Zhang CY, Jukic AMZ, Baird DD, Coull BA, Hauser R, Mahalingaiah S, Zhang S, Curry CL. Performance of algorithms using wrist temperature for retrospective ovulation day estimate and next menses start day prediction: a prospective cohort study. Hum Reprod. 2025 Mar 1;40(3):469-478. doi: 10.1093/humrep/deaf005.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Contract research organization', 'healthyVolunteers': False, 'eligibilityCriteria': '* At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi)\n* Can communicate in written and spoken English\n* Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi\n* Access to reliable Wifi in the bedroom\n* Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype\n* Able to read and understand the written consent form\n* Reside in the US for the duration of the study'}, 'identificationModule': {'nctId': 'NCT05852951', 'briefTitle': 'Cycle and Ovulation Study Expansion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apple Inc.'}, 'officialTitle': 'Cycle and Ovulation Study Expansion', 'orgStudyIdInfo': {'id': 'Pro00054031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Menstrual patterns', 'description': 'Regular menstrual cycles and irregular menstrual cycles; irregular menstrual cycles are defined as having variation in menstrual cycles of greater than 2 days and less than 2 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Exponent', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Bo Qing, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Exponent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apple Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Exponent', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}