Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT00802295
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2008-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aneuploidies and Different Stimulation Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000782', 'term': 'Aneuploidy'}], 'ancestors': [{'id': 'D002869', 'term': 'Chromosome Aberrations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006062', 'term': 'Gonadotropins'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aneuploidy rate with two different stimulation protocols.', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'Normal blastocyst rate', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian', 'hyperstimulation', 'Embryo', 'Aneuploidy', 'Ovarian hyperstimulation and Embryo Aneuploidy Rates'], 'conditions': ['Aneuploidy']}, 'referencesModule': {'references': [{'pmid': '20627979', 'type': 'DERIVED', 'citation': 'Rubio C, Mercader A, Alama P, Lizan C, Rodrigo L, Labarta E, Melo M, Pellicer A, Remohi J. Prospective cohort study in high responder oocyte donors using two hormonal stimulation protocols: impact on embryo aneuploidy and development. Hum Reprod. 2010 Sep;25(9):2290-7. doi: 10.1093/humrep/deq174. Epub 2010 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (\\>20 oocytes and/or E2 levels the day of the hCG injection \\>3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women between 18 - 29\n* with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (\\> 20 oocytes)\n* No symptom of OHSS\n\nExclusion Criteria:\n\n* donors with 2 previous miscarriages\n* PCO\n* Severe Male Factor'}, 'identificationModule': {'nctId': 'NCT00802295', 'briefTitle': 'Aneuploidies and Different Stimulation Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Influence of Ovarian Stimulation and Embryo Aneuploidy', 'orgStudyIdInfo': {'id': 'VLC-JR-0204-307-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard dosis protocol', 'description': 'Administration of standard dosis of gonadotrophins for ovarian stimulation.', 'interventionNames': ['Drug: Gonadotrophins']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Administration of low dosis of Gonadotrophins for ovarian stimulation', 'interventionNames': ['Drug: Low dosis Gonadotrophin']}], 'interventions': [{'name': 'Gonadotrophins', 'type': 'DRUG', 'description': 'Administration of standard ovarian stimulation protocol', 'armGroupLabels': ['standard dosis protocol']}, {'name': 'Low dosis Gonadotrophin', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Infertilidad', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Jose Remohi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jose Remohi Jimenez', 'oldOrganization': 'IVI Valencia'}}}}