Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT01636505
Status:
UNKNOWN
Last Update Posted:
2012-07-10
First Post:
2012-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D002064', 'term': 'Buserelin'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-09', 'studyFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol', 'timeFrame': 'one year', 'description': "difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Embryo's Genetic and Chromosomal Quality"]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.\n\nPatients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.\n\nThe end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.\n\nThe patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.\n\nThe uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients carrier genetic disease\n* advanced maternal Age\n* repeated IVF failure\n* recurrent pregnancy loss\n\nExclusion Criteria:\n\n* uterine abnormalities\n* endometriosis\n* endocrinal diseases'}, 'identificationModule': {'nctId': 'NCT01636505', 'briefTitle': 'The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol', 'organization': {'class': 'OTHER', 'fullName': 'European Hospital'}, 'orgStudyIdInfo': {'id': 'ECK011170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'short protocol', 'description': 'gnrh agonist versus gnrh antagonist', 'interventionNames': ['Drug: ghrh antagonist (cetrotide/orgalutran)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'long protocol', 'interventionNames': ['Drug: gnrh agonist (suprefact)']}], 'interventions': [{'name': 'ghrh antagonist (cetrotide/orgalutran)', 'type': 'DRUG', 'description': 'cetrotide/orgalutran 0.25 mg', 'armGroupLabels': ['short protocol']}, {'name': 'gnrh agonist (suprefact)', 'type': 'DRUG', 'description': 'suprefact 5.5 ml', 'armGroupLabels': ['long protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00148', 'city': 'Rome', 'country': 'Italy', 'contacts': [{'name': 'Ermanno Greco, MD', 'role': 'CONTACT', 'email': 'ergreco@virgilio.it', 'phone': '06-65975643'}, {'name': 'Ermanno greco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}