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

March 29, 2007
March 3, 2011
November 2007
December 2008   (final data collection date for primary outcome measure)
impact of biopsy [ Time Frame: 8 days ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00454311 on ClinicalTrials.gov Archive Site
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The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening
Prospective and Randomized Study of the Impact of the Biopsy of 1-2 Cells in a PGD Program for Aneuploidy Screening

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Healthy
  • Procedure: Biopsy of Day 3 Embryo
  • Procedure: · day embryo biopsy
  • Active Comparator: One cell biopsy
    Intervention: Procedure: · day embryo biopsy
  • Two cell biopsy
    Intervention: Procedure: Biopsy of Day 3 Embryo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
25 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00454311
VLC-CR-1106-307-5
No
Dr. Carmen Rubio, IVI Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA
Not Provided
Principal Investigator: Carmen Rubio, PhD Instituto Valenciano de Infertilidad
Instituto Valenciano de Infertilidad, IVI VALENCIA
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP