Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-05-22 @ 4:09 AM
Study NCT ID:
NCT02814006
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Timing in Couples Actively Trying to Conceive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': '2016-06-24', '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 sexual functioning over the course of one year', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]', 'description': 'Self-report measure (FSFI, Rosen et al., 2000; IIEF, Rosen et al., 1997)'}], 'secondaryOutcomes': [{'measure': 'Change in Depression over the course of one year', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]', 'description': 'Self-report measure (HADS, \\& Snaith Zigmund, 1994)'}, {'measure': 'Change in Anxiety over the course of one year', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]', 'description': 'Self-report measure (HADS, \\& Snaith Zigmund, 1994)'}, {'measure': 'Number of participants that attain an infertility diagnosis', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]'}, {'measure': 'Number of participants that achieve conception', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]'}, {'measure': 'Change in social support over the course of one year', 'timeFrame': 'T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]', 'description': 'Self-report measure (2WSS, Shakespeare-finch \\& Obst, 2011)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['marital relationship'], 'conditions': ['Conception']}, 'referencesModule': {'references': [{'pmid': '36272105', 'type': 'DERIVED', 'citation': 'Martins MV, Fernandes J, Pedro J, Barros A, Xavier P, Schmidt L, Costa ME. Effects of trying to conceive using an every-other-day strategy versus fertile window monitoring on stress: a 12-month randomized controlled trial. Hum Reprod. 2022 Nov 24;37(12):2845-2855. doi: 10.1093/humrep/deac228.'}]}, 'descriptionModule': {'briefSummary': 'This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Note: age limits are for female age only\n\nInclusion Criteria:\n\n* Childless couples trying to conceive\n* Relationship length \\> one year\n\nExclusion Criteria:\n\n* Couples that already had achieved a successful pregnancy\n* Couples with children'}, 'identificationModule': {'nctId': 'NCT02814006', 'acronym': 'SEXTACTIC', 'briefTitle': 'Sexual Timing in Couples Actively Trying to Conceive', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'What is the Best Sexual Intercourse Strategy for Couples Actively Trying to Conceive?', 'orgStudyIdInfo': {'id': 'FPCEUP/RH3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'every other day', 'description': 'participants will visualize educational video with timed intercourse as recommended by NICE and ASRM', 'interventionNames': ['Other: health educational video']}, {'type': 'EXPERIMENTAL', 'label': 'fertile window', 'description': 'participants will visualize educational video with timed intercourse as recommended by well-know evidence of better conception rates when using this strategy', 'interventionNames': ['Other: health educational video']}, {'type': 'NO_INTERVENTION', 'label': 'CG', 'description': 'participants will respond to questionnaire with no knowledge of intervention'}], 'interventions': [{'name': 'health educational video', 'type': 'OTHER', 'description': 'visualization of health educational video', 'armGroupLabels': ['every other day', 'fertile window']}]}, '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': 'Mariana V Martins, PhD', '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'}}}}