Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-28 @ 5:32 AM
Study NCT ID:
NCT06128395
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASA 81 mg vs 162 mg During Frozen Embryo Transfer (FET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare clinical pregnancy rate between patients prescribed Aspirin 81 mg vs Aspirin 162 mg', 'timeFrame': 'Time Frame: 6 to 8 weeks after Frozen Embryo Transfer', 'description': 'clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertility Disorders']}, 'descriptionModule': {'briefSummary': 'The use of low dose aspirin is recommended for high risk patients to reduce the risk of pre-eclampsia, placental abruption and antepartum hemorrhage. Recent studies have shown that in a specific population, the use of low dose aspirin might reduce the risk of preterm birth in pregnant women with singleton pregnancy. In June 2022, clinique ovo started implementing the use of Aspirin 162 mg instead of 81 mg in the frozen embryo transfer cycles based on recent study outcomes. The use of Aspirin 162 mg might have additional benefits on the embryo transfer outcomes by decreasing the miscarriage. Moreover this can be continued until late in pregnancy without adverse effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'FET Data spreadsheet from January 2022 to December 2022', 'genderDescription': 'Women able to have an embryo transfered in their uterus', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women taking aspirin 81 mg or 162 mg prior to an autologous embryo transfer\n* Age \\< 40 years old\n* Embryo transfer cycle done at clinique ovo\n\nExclusion Criteria:\n\n* Egg or embryo recipient\n* History of recurrent miscarriages, defined as ≥ 3 consecutive losses\n* Patients that needed Viagra, PRP or other modalities to improve their endometrial thickness\n* Uterine factor infertility\n* Abnormal hormonal profiles\n* Stimulated embryo transfer cycles\n* History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts'}, 'identificationModule': {'nctId': 'NCT06128395', 'briefTitle': 'ASA 81 mg vs 162 mg During Frozen Embryo Transfer (FET)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinique Ovo'}, 'officialTitle': 'Retrospective Study to Assess if Aspirin 162 mg is Better Than 81 mg for Embryo Transfer Outcomes', 'orgStudyIdInfo': {'id': '3384'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aspirin 81 mg for Frozen Embryo Transfer (FET)', 'description': 'Subjects were prescribed Aspirin 81 mg to be started on the third day of their menstrual cycle in preparation for their FET.', 'interventionNames': ['Other: Frozen embryo transfer']}, {'label': 'Aspirin 162 mg for Frozen Embryo Transfer (FET)', 'description': 'Subjects were prescribed Aspirin 162 mg to be started on the third day of their menstrual cycle in preparation for their FET', 'interventionNames': ['Other: Frozen embryo transfer']}], 'interventions': [{'name': 'Frozen embryo transfer', 'type': 'OTHER', 'description': 'A frozen embryo transfer involves thawing a fertilized embryo and transferring it in the uterus in order to obtain a pregnancy', 'armGroupLabels': ['Aspirin 162 mg for Frozen Embryo Transfer (FET)', 'Aspirin 81 mg for Frozen Embryo Transfer (FET)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4P 2S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Ovo', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Wael Jamal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Ovo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Ovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}