Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-29 @ 12:00 PM
Study NCT ID:
NCT02133950
Status:
UNKNOWN
Last Update Posted:
2014-05-08
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Segmentation of PGD Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011457', 'term': 'Prostaglandins D'}], 'ancestors': [{'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative live birth rate of a single PGD treatment', 'timeFrame': '1 year', 'description': 'cumulative LBR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['preimplantation genetic diagnosis', 'cryopreservation', 'pregnancy'], 'conditions': ['Clinical Pregnancy', 'Live Birth']}, 'referencesModule': {'references': [{'pmid': '33539543', 'type': 'DERIVED', 'citation': 'Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.'}]}, 'descriptionModule': {'briefSummary': 'A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of the study is to assess the feasibility and effectiveness of segmentation in terms of pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD cycles.\n\nExperimental questions\n\n1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically transferable embryos are cryopreserved by vitrification prior to consecutive in utero transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer cumulative with transfer of supernumerary cryopreserved embryos?\n2. Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?\n\nDesign The proposed design is a pragmatic, prospective randomised controlled trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1st, 2nd or 3rd cycle of PGD in which embryo transfer was performed\n* Indications for PGD: monogenic indications and X-linked disorders with a 25-50% risk of transmission and that are not associated with reduced ovarian response\n* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.\n* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.\n\nExclusion Criteria:\n\n* POLYCYSTIC OVARIAN SYNDROME (Rotterdam criteria \\*)\n\n \\* At least two of the following three features: (i) Oligo- and/or anovulation (ii) Clinical and/or biochemical signs of hyperandrogenism (iii) Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumours, Cushing's syndrome)\n* Poor responders (Bologna criteria \\*\\*)\n\n \\* \\* At least two of the following three features: (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (POR); (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles, or anti-Mullerian hormone (AMH) 0.5-1.1 ng/ml).\n* Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)\n* anticipated high response: AMH \\>5.0 ng/ml or AFC \\>20\n* Endometriosis ≥ grade 3\n* Age \\> 40 years and 364 days"}, 'identificationModule': {'nctId': 'NCT02133950', 'briefTitle': 'Efficacy Study of Segmentation of PGD Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'A Single Centre Randomised Controlled Study Into the Segmentation of Preimplantation Genetic Diagnosis (PGD) Treatment by Comparing Cumulative Pregnancy Rates Following Cryopreservation of All Genetically Transferable Embryos After PGD, Compared to Fresh Embryo Transfer Cumulative With Frozen Embryo Transfer of Genetically Transferable Embryos.', 'orgStudyIdInfo': {'id': 'B.U.N. 143201420647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'freeze all embryos following PGD', 'description': 'no fresh embryo transfer; elective cryopreservation of all embryos after PGD', 'interventionNames': ['Procedure: elective cryopreservation of available embryos after PGD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'elective fresh embryo transfer', 'interventionNames': ['Procedure: PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD']}], 'interventions': [{'name': 'elective cryopreservation of available embryos after PGD', 'type': 'PROCEDURE', 'otherNames': ['freeze all embryos'], 'description': 'no elective fresh embryo transfer; freeze all', 'armGroupLabels': ['freeze all embryos following PGD']}, {'name': 'PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD', 'type': 'PROCEDURE', 'otherNames': ['fresh ET'], 'description': 'PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD', 'armGroupLabels': ['elective fresh embryo transfer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'contacts': [{'name': 'WILLEM MJA VERPOEST, MD PHD', 'role': 'CONTACT', 'phone': '+3224776699'}], 'facility': 'Centre for Reproductive Medicine UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'centralContacts': [{'name': 'WILLEM MJA VERPOEST, MD PHD', 'role': 'CONTACT', 'phone': '+3224776699'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor dr', 'investigatorFullName': 'VERPOEST WILLEM', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}