Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-03-10 @ 6:18 PM
Study NCT ID:
NCT03939403
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2019-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-07', 'releaseDate': '2023-03-02'}], 'estimatedResultsFirstSubmitDate': '2023-03-02'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of oocytes', 'timeFrame': 'At the end of stimulation', 'description': 'Number of oocytes after stimulation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation).\n\nThis a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for oocyte donation program\n* Age between 18 and 32 years old\n* BMI \\>18 and \\<30\n* Antral follicle count \\>12 (summing both ovaries)\n* Presence of both ovaries\n* Ability to participate in and comply with study protocol\n* Signed informed consent\n* No treatment with ovulation stimulators in the 3 months prior to the start of stimulation.\n\nExclusion Criteria:\n\n* Diagnosis of endometriosis at any stage\n* AFC \\>20\n* Polycystic ovary syndrome\n* Concurrent participation in another study'}, 'identificationModule': {'nctId': 'NCT03939403', 'acronym': 'TAIL', 'briefTitle': 'Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Bernabeu'}, 'officialTitle': 'Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study', 'orgStudyIdInfo': {'id': 'IB-0319-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7-days pill free interval', 'interventionNames': ['Drug: Time of administration of Corifollitropin Alfa']}, {'type': 'NO_INTERVENTION', 'label': '5-days pill free interval'}], 'interventions': [{'name': 'Time of administration of Corifollitropin Alfa', 'type': 'DRUG', 'description': 'The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.\n\nThe control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.\n\nThe intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use.', 'armGroupLabels': ['7-days pill free interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03016', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Instituto Bernabeu', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Bernabeu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joaquín Llácer', 'investigatorAffiliation': 'Instituto Bernabeu'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-02', 'type': 'RELEASE'}, {'date': '2023-12-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Joaquín Llácer, Principal Investigator, Instituto Bernabeu'}}}}