The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00454311
First received: March 29, 2007
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

The aim of this study is to evaluate the impact of the biopsy of one or two cells in a preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This prospective and randomized study will be performed at the Instituto Valenciano de Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our purpose is to optimize the methodology employed in our laboratory in order to guarantee optimal implantation and pregnancy rates without a detrimental effect on the accuracy and efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours and chormosomally normal embryos will be replaced into the uterus on day 5 of development.


Condition Intervention
Healthy
Procedure: Biopsy of Day 3 Embryo
Procedure: · day embryo biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prospective and Randomized Study of the Impact of the Biopsy of 1-2 Cells in a PGD Program for Aneuploidy Screening

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

Primary Outcome Measures:
  • impact of biopsy [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One cell biopsy Procedure: · day embryo biopsy
Two cell biopsy Procedure: Biopsy of Day 3 Embryo

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing PGD for aneuploidy screening with their own oocytes and for chromosomes 13, 16, 18, 21, 22, X & Y

Exclusion Criteria:

  • Patients undergoing PGD for monogenic diseases (PCR)
  • Patients undergoing PGD for structural chromosomal abnormalities
  • Ovum donation cycles
  • Cryopreserved oocyte/embryos
  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: NCT00454311

Locations
Spain
Instituto Valenciano de la Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: Carmen Rubio, PhD Instituto Valenciano de Infertilidad
  More Information

No publications provided

Responsible Party: Dr. Carmen Rubio, IVI Valencia
ClinicalTrials.gov Identifier: NCT00454311     History of Changes
Other Study ID Numbers: VLC-CR-1106-307-5
Study First Received: March 29, 2007
Last Updated: March 3, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
Pregnancy and implantation rates
Efficiency and accuracy of the genetic testing

ClinicalTrials.gov processed this record on September 18, 2014