Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-02 @ 12:43 PM
Study NCT ID:
NCT02813993
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Couples Fertility and Pregnancy Awareness
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fertility knowledge', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later', 'description': 'This measure assesses fertility knowledge by asking questions on the probability of conception and fertility treatment success rates, infertility definition and infertility risk factors'}], 'secondaryOutcomes': [{'measure': 'Change in number of months planned to get pregnant/pregnancy', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later', 'description': 'This question measures the number of months estimated by participants until they get pregnant or pregnancy'}, {'measure': 'Change in intention and adoption of fertility-optimizing behaviors', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later', 'description': 'These questions assessed the intentions to adopt and the effective adoption of fertility-optimizing behaviors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infertility', 'fertility awareness', 'preconceptional care', 'health interventions', 'couples'], 'conditions': ['Fertility; Decision to Get Pregnant']}, 'descriptionModule': {'briefSummary': 'Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.', 'detailedDescription': 'This study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. The couples will be randomized to the two groups. The video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female member of the couples has between 24 to 40 years\n* Childless couples trying to conceive or couples who desired to have children in the next 3 years\n* Relationship length minimum of one year\n\nExclusion Criteria:\n\n* Couples that already had achieved a successful pregnancy\n* Couples with children'}, 'identificationModule': {'nctId': 'NCT02813993', 'acronym': 'CFPA', 'briefTitle': 'Couples Fertility and Pregnancy Awareness', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Couples Fertility and Pregnancy Awareness', 'orgStudyIdInfo': {'id': 'FPCEUP/RH2'}, 'secondaryIdInfos': [{'id': 'SFRH/BD/103234/2014', 'type': 'OTHER_GRANT', 'domain': 'Fundação para a Ciência e Tecnologia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'A five-minute video concerning age-related fertility decline, fertility risk factors, success of infertility treatments and emotional consequences of childlessness', 'interventionNames': ['Other: Health educational video']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Health educational video', 'type': 'OTHER', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-193', 'city': 'Porto', 'country': 'Portugal', 'facility': 'University of Porto, Faculty of Psychology and Educational and Education Sciences', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Juliana Pedro, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação para a Ciência e a Tecnologia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}