Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02796105
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2016-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061018', 'term': 'ganirelix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'donor ovarian response', 'timeFrame': '1 month'}]}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '30927417', 'type': 'DERIVED', 'citation': 'Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oocyte donors included in the oocyte donation program of Clinica EUGIN.\n* 1st oocyte donation cycle at Clínica EUGIN.\n\nExclusion Criteria:\n\n* Polycistic Ovarian syndrome (PCOs).\n* Estradiol levels on day 2 of menstrual cycle \\>70 pg/ml.\n* Hormone treatments up to 3 months before the oocyte donation cycle.\n* Medical contraindication to the treatments used in the study'}, 'identificationModule': {'nctId': 'NCT02796105', 'briefTitle': 'Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Privada Eugin'}, 'officialTitle': 'Evaluation of Efficacy and Safety of Medroxiprogesterone Acetate (Progevera 10 mg®) Versus GnRh Antagonist (Orgalutran®) in Ovarian Stimulation Cycles of Oocyte Donors', 'orgStudyIdInfo': {'id': 'BRAKE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progevera', 'description': 'Progevera 10 mg', 'interventionNames': ['Drug: Progevera']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Orgalutran', 'description': 'Orgalutran 0.25 mg', 'interventionNames': ['Drug: Orgalutran']}], 'interventions': [{'name': 'Progevera', 'type': 'DRUG', 'armGroupLabels': ['Progevera']}, {'name': 'Orgalutran', 'type': 'DRUG', 'armGroupLabels': ['Orgalutran']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Clinica Eugin', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Rebeca Begueria, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Eugin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Privada Eugin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}