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Sponsored by: |
Instituto Valenciano de Infertilidad, Spain |
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Information provided by: | Instituto Valenciano de Infertilidad, Spain |
ClinicalTrials.gov Identifier: | NCT00795795 |
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.
In 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.
Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:
Condition | Intervention |
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Chromosomal Abnormalities |
Procedure: Preimplantation Genetic Screening Procedure: IVF without PGS |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA) |
Estimated Enrollment: | 640 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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with PGS: Active Comparator
IVF cycles with Preimplantation Genetic Screening (PGS)
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Procedure: Preimplantation Genetic Screening
Preimplantation Genetic Screening
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Without PGS: Active Comparator
IVF cycle without Preimplantation Genetic Screening
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Procedure: Preimplantation Genetic Screening
Preimplantation Genetic Screening
Procedure: IVF without PGS
IVF without PGS
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Ages Eligible for Study: | 38 Years to 44 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carmen Rubio, PhD | 34 963050900 | c.rubio@ivi.es |
Contact: Leslie Atkinson, Ma | 34 963050900 | latkinson@ivi.es |
Spain | |
Instituto Valenciano de Infertilidad | |
Valencia, Spain, 46015 |
Responsible Party: | Instituto Valenciano de Infertilidad ( Dr Carmen Rubio ) |
Study ID Numbers: | 0802-C-046-CR |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795795 |
Health Authority: | Spain: Ministry of Health |
Chromosomal abnormalities in preimplantation embryos |
Chromosomal abnormalities Genetic Diseases, Inborn Chromosome Aberrations Chromosome Disorders Congenital Abnormalities |
Pathologic Processes |