Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT05677828
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SMART Protocol vs Antagonist Protocol in IVF
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of utilizable blastocysts obtained', 'timeFrame': 'approximately 20 days', 'description': 'Comparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVF', 'Fertility issues'], 'conditions': ['Diminished Ovarian Reserve']}, 'descriptionModule': {'briefSummary': 'This retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole.', 'detailedDescription': 'A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF is associated with an increase in oocyte count, blastocyst count and implantation rate. These differences are presumed to be caused by an increase in intra-ovarian androgens associated with the addition of letrozole.\n\nIn patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle, supplementation with of letrozole has the potential to increase oocyte count or oocyte quality, thereby resulting in more transferable blastocysts. The antagonist stimulation protocol with the addition of letrozole is commonly referred to as the SMART protocol (Stimulation with Minimal Adverse effects, Retrieval and Transfer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective cohort study will analyze IVF cycles in antagonist and SMART stimulation protocols during the period from 2010 to 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for the SMART IVF protocol:\n\n* Women between the ages of 20 and 42 inclusively\n* Women proceeding with a SMART IVF protocol following an antagonist IVF protocol between 2010 and 2020 (study group) or women proceeding with an antagonist protocol following an antagonist IVF protocol between 2010 and 2020 (control group)\n* Delay of 1 year between both IVF cycle\n\nExclusion Criteria:\n\n* Women undergoing fertility preservation\n* Oocyte donation IVF cycles\n* Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)'}, 'identificationModule': {'nctId': 'NCT05677828', 'briefTitle': 'SMART Protocol vs Antagonist Protocol in IVF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinique Ovo'}, 'officialTitle': 'Effect of the Addition of Letrozole in in Vitro Fertilization (IVF) Following a Prior Failed IVF Cycle With an Antagonist or Short Protocol Without Letrozole', 'orgStudyIdInfo': {'id': 'CCER 21-22 - 21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antagonist - SMART', 'description': 'Women who have had a SMART IVF stimulation cycle with Letrozole after a failed antagonist IVF stimulation cycle between 2010 and 2020.'}, {'label': 'Antagonist - Antagonist', 'description': 'Women who have had an antagonist stimulation IVF cycle after a previously failed antagonist IVF stimulation cycle between 2010 and 2020.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4P 2S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Ovo', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Robert Hemmings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Ovo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Ovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}