Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-27 @ 12:19 PM
Study NCT ID:
NCT05033366
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-19
First Post:
2021-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Fertility Hormone Patterns and Pregnancy Rates.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-17', 'studyFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self reported pregnancy', 'timeFrame': 'Two menstrual cycle, up to 45 days each', 'description': 'Questionnaire used to assess if positive Proov test strips measuring urine PDG correlate with increased rates of self reported pregnancy'}], 'secondaryOutcomes': [{'measure': 'self reported first trimester pregnancy loss', 'timeFrame': 'Three months', 'description': 'Questionnaire used to assess if negative Proov test strips measuring urine PDG correlate with increased rates of self reported first trimester pregnancy loss'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if certain patterns of hormone levels during the menstrual cycle are correlated with different pregnancy outcomes.', 'detailedDescription': 'Proov tests are fertility tracking tests. They are used for monitoring ovulation at home, and are able to measure one or more hormones. These hormones can predict and confirm ovulation. Tracking these hormones can help a woman understand if she is ovulating, and can help to identify problems that could be preventing pregnancy.\n\nAfter giving permission to access your testing history collected in the Proov app from March 2020 to April 2022, you will complete an online survey about your fertility test results and pregnancy status. You will also be asked information regarding your age, race, smoking status, and BMI. Your test results logged in the Proov app will be shared automatically. You will need 10-20 minutes to fill out the fertility survey.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females age 18 - no limit who are using, or have used, the Proov hormone test strips and the Proov app for at least one full cycle.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. Age 18 - no limit\n3. Have completed one full cycle using the Proov app\n\nExclusion Criteria:\n\n1. Male\n2. Have not completed one full cycle using the Proov app'}, 'identificationModule': {'nctId': 'NCT05033366', 'briefTitle': 'Relationship Between Fertility Hormone Patterns and Pregnancy Rates.', 'organization': {'class': 'INDUSTRY', 'fullName': 'MFB Fertility'}, 'officialTitle': 'Relationship Between Fertility Hormone Patterns and Pregnancy Rates.', 'orgStudyIdInfo': {'id': '2021/03/29'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Proov test strip users that record results with the Proov app', 'description': 'Participants using Proov test strips along with the Proov app who have logged at least one complete cycle will be asked to complete an online survey about fertility test results and current/previous pregnancy status. They will also be asked cycle history (irregular vs regular, cycle length), fertility testing (partners semen analysis results, AMH level, HSG results), possible fertility medications taken or prescribed, age, race, smoking status, and BMI.', 'interventionNames': ['Diagnostic Test: Proov Test']}], 'interventions': [{'name': 'Proov Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Rapid response urine PdG, FSH, E1G and LH test strips, Proov', 'armGroupLabels': ['Proov test strip users that record results with the Proov app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'MFB Fertility', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Amy Beckely, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MFB Fertility'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only cohort data will be released'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MFB Fertility', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}