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Preimplantation Genetic Screening in Women of Advanced Maternal Age
This study is not yet open for participant recruitment.
Verified by Instituto Valenciano de Infertilidad, Spain, November 2008
Sponsored by: Instituto Valenciano de Infertilidad, Spain
Information provided by: Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00795795
  Purpose

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:

  • Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed
  • 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.

Condition Intervention
Chromosomal Abnormalities
Procedure: Preimplantation Genetic Screening
Procedure: IVF without PGS

MedlinePlus related topics: Genetic Testing
U.S. FDA Resources
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)

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • ongoing implantation per embryo and per pacient [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Take home baby [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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
with PGS: Active Comparator
IVF cycles with Preimplantation Genetic Screening (PGS)
Procedure: Preimplantation Genetic Screening
Preimplantation Genetic Screening
Without PGS: Active Comparator
IVF cycle without Preimplantation Genetic Screening
Procedure: Preimplantation Genetic Screening
Preimplantation Genetic Screening
Procedure: IVF without PGS
IVF without PGS

  Eligibility

Ages Eligible for Study:   38 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female Patients over 37 years old, attending a fertility clinic

Exclusion Criteria:

  • Azoospermic partners
  • Female patients with uterine malformations
  • number of retreived oocytes below 5
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795795

Contacts
Contact: Carmen Rubio, PhD 34 963050900 c.rubio@ivi.es
Contact: Leslie Atkinson, Ma 34 963050900 latkinson@ivi.es

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

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

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Chromosomal abnormalities in preimplantation embryos

Study placed in the following topic categories:
Chromosomal abnormalities
Genetic Diseases, Inborn
Chromosome Aberrations
Chromosome Disorders
Congenital Abnormalities

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009