Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:54 AM
Study NCT ID:
NCT00795795
Status:
COMPLETED
Last Update Posted:
2012-04-02
First Post:
2008-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preimplantation Genetic Screening in Women of Advanced Maternal Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002869', 'term': 'Chromosome Aberrations'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010715', 'term': 'Phosphatidylglycerols'}], 'ancestors': [{'id': 'D020404', 'term': 'Glycerophospholipids'}, {'id': 'D010712', 'term': 'Phosphatidic Acids'}, {'id': 'D005994', 'term': 'Glycerophosphates'}, {'id': 'D010743', 'term': 'Phospholipids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-30', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing implantation per embryo and per pacient', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Take home baby', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chromosomal abnormalities in preimplantation embryos'], 'conditions': ['Chromosomal Abnormalities']}, 'descriptionModule': {'briefSummary': 'An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients.\n\nIn our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits.\n\nTherefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:\n\n* Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed\n* Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '38 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Patients over 37 years old, attending a fertility clinic\n\nExclusion Criteria:\n\n* Azoospermic partners\n* Female patients with uterine malformations\n* number of retreived oocytes below 5'}, 'identificationModule': {'nctId': 'NCT00795795', 'briefTitle': 'Preimplantation Genetic Screening in Women of Advanced Maternal Age', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA)', 'orgStudyIdInfo': {'id': '0802-C-046-CR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'with PGS', 'description': 'IVF cycles with Preimplantation Genetic Screening (PGS)', 'interventionNames': ['Procedure: Preimplantation Genetic Screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without PGS', 'description': 'IVF cycle without Preimplantation Genetic Screening', 'interventionNames': ['Procedure: Preimplantation Genetic Screening', 'Procedure: IVF without PGS']}], 'interventions': [{'name': 'Preimplantation Genetic Screening', 'type': 'PROCEDURE', 'description': 'Preimplantation Genetic Screening', 'armGroupLabels': ['Without PGS', 'with PGS']}, {'name': 'IVF without PGS', 'type': 'PROCEDURE', 'description': 'IVF without PGS', 'armGroupLabels': ['Without PGS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Infertilidad', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Carmen Rubio', 'oldOrganization': 'Instituto Valenciano de Infertilidad'}}}}