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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: · day embryo biopsy; Procedure: Biopsy of Day 3 Embryo

• Registration Number: NCT00454311
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-29
• Study First Posted: 2007-03-30
• Study Start: 2007-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One cell biopsy	· day embryo biopsy	-
Two cell biopsy	Biopsy of Day 3 Embryo	-

Primary Outcome Measures

Name	Time	Method
impact of biopsy	8 days

Trial Locations

Locations (1)

Instituto Valenciano de la Infertilidad; 🇪🇸 Valencia, Spain