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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00454311

Enrollment

Unknown

Registered

2007-03-30

Start date

2007-11-30

Completion date

2008-12-31

Last updated

2011-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pregnancy and implantation rates, Efficiency and accuracy of the genetic testing

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.

Interventions

PROCEDUREBiopsy of Day 3 Embryo

PROCEDURE· day embryo biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

25 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
impact of biopsy	8 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026