Trial record 9 of 497 for:    "tetrasomy 18p" OR "Chromosomal Disorder"

Preimplantation Genetic Screening in Women of Advanced Maternal Age

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00795795
First received: November 20, 2008
Last updated: March 30, 2012
Last verified: March 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA)

Resource links provided by NLM:


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

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
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: with PGS
IVF cycles with Preimplantation Genetic Screening (PGS)
Procedure: Preimplantation Genetic Screening
Preimplantation Genetic Screening
Active Comparator: Without PGS
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795795

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

No publications provided

Responsible Party: Dr Carmen Rubio, Instituto Valenciano de Infertilidad
ClinicalTrials.gov Identifier: NCT00795795     History of Changes
Other Study ID Numbers: 0802-C-046-CR
Study First Received: November 20, 2008
Last Updated: March 30, 2012
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
Congenital Abnormalities
Chromosome Aberrations
Chromosome Disorders
Pathologic Processes
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 29, 2014