Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 3:17 PM
Study NCT ID:
NCT01177904
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2010-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Progesterone Cessation After in Vitro Fertilization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'graciela.kohls@ivi.es', 'phone': '91 180 29 00', 'title': 'Dr. Graciela Kohls', 'organization': 'IVI Madrid'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group : P4 8 Weeks', 'description': 'Progesterone will be given until 8 weeks of pregnancy', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Study Group: P4 5 Weeks', 'description': 'Progesterone will be given until 5 weeks of pregnancy', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Bleeding Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group : P4 8 Weeks', 'description': 'Progesterone will be given until 8 weeks of pregnancy\n\ncontrol group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy'}, {'id': 'OG001', 'title': 'Study Group', 'description': 'The study group stop receiving progesterone on the day of their first Ultra-sound at 5 weeks pregnancy\n\nCease progesterone at 5: Cease administration of progesterone at first Ultra-sound at 5 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '10', 'groupId': 'OG000'}, {'value': '8', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to year', 'description': 'Number of bleeding episodes up to a year', 'unitOfMeasure': 'Episodes of bleeding', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Progesterone 5 Weeks', 'description': 'The study group stop receiving progesterone on the day of their first Ultra-sound at 5 weeks pregnancy\n\nCease progesterone at 5: Cease administration of progesterone at first Ultra-sound at 5 weeks'}, {'id': 'FG001', 'title': 'Control Group : Progesterone 8 Weeks', 'description': 'Progesterone will be given until 8 weeks of pregnancy\n\ncontrol group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Progesterone during 1st trimester'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Progesterone 5 Weeks', 'description': 'The study group of women stop receiving P4 on the day of their first US at 5 weeks pregnancy\n\nCease progsterone at 5: Cease administration of progsterone at first US at 5 weeks'}, {'id': 'BG001', 'title': 'Control Group : P4 8 Weeks', 'description': 'Progesterone will be given until 8 weeks of pregnancy\n\ncontrol group: progesterone 8: Control group: progesterone until 8 weeks of pregnancy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bleeding Episodes', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '4', 'groupId': 'BG000'}, {'value': '8', 'spread': '4', 'groupId': 'BG001'}, {'value': '8', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Bleeding Episodes in each group.', 'unitOfMeasure': 'Bleeding episodes', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Women'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2010-08-05', 'resultsFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2010-08-06', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-05', 'studyFirstPostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Bleeding Episodes', 'timeFrame': 'Up to year', 'description': 'Number of bleeding episodes up to a year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnant Women']}, 'referencesModule': {'references': [{'pmid': '22749223', 'type': 'DERIVED', 'citation': 'Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.', 'detailedDescription': 'The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.\n\nPatients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.\n\nAll patients which show a gestational sac in their uterus in the first US are included in this study and randomized.\n\nInclusion criteria:\n\n1. Patients who underwent ovarian stimulation using GnRH analogues,\n2. Fresh embryo transfer,\n3. LPS by vaginal micronized P4,\n4. Clinical pregnancy demonstrated by US and\n5. Informed consent signed.\n\nExclusion criteria:\n\nPatients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who underwent ovarian stimulation using GnRH analogues,\n2. Fresh embryo transfer,\n3. LPS by vaginal micronized P4,\n4. Clinical pregnancy demonstrated by US and\n5. Informed consent signed.\n\nExclusion Criteria:\n\nPatients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.'}, 'identificationModule': {'nctId': 'NCT01177904', 'briefTitle': 'Early Progesterone Cessation After in Vitro Fertilization', 'organization': {'class': 'OTHER', 'fullName': 'IVI Madrid'}, 'officialTitle': 'Early Progesterone Cessation After in Vitro Fertilization', 'orgStudyIdInfo': {'id': 'MAD-GK-01-2009-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Progesterone 5 Weeks', 'description': 'The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy', 'interventionNames': ['Other: Cease progsterone at 5']}, {'type': 'OTHER', 'label': 'Control Group : P4 8 weeks', 'description': 'Progesterone will be given until 8 weeks of pregnancy', 'interventionNames': ['Other: control group: progesterone 8']}], 'interventions': [{'name': 'Cease progsterone at 5', 'type': 'OTHER', 'description': 'Cease administration of progsterone at first US at 5 weeks', 'armGroupLabels': ['Progesterone 5 Weeks']}, {'name': 'control group: progesterone 8', 'type': 'OTHER', 'description': 'Control group: progesterone until 8 weeks of pregnancy', 'armGroupLabels': ['Control Group : P4 8 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'IVI-Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Juan A Garcia-Velasco, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IVI Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologist', 'investigatorFullName': 'Graciela Kohls', 'investigatorAffiliation': 'IVI Madrid'}}}}