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

March 3, 2011 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • Instituto Valenciano de la Infertilidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: One cell biopsy
Procedure: · day embryo biopsy
OTHER: Two cell biopsy
Procedure: Biopsy of Day 3 Embryo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
impact of biopsy
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

  • Principal Investigator: Carmen Rubio, PhD, Instituto Valenciano de Infertilidad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (ESTIMATE)

March 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VLC-CR-1106-307-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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