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

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status: Completed

Conditions: Healthy

Treatments: Procedure: · day embryo biopsy; Procedure: Biopsy of Day 3 Embryo

Study type: Interventional

Funder types: Other

Identifiers

NCT00454311

VLC-CR-1106-307-5

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

One cell biopsy

Active Comparator group

Treatment:

Procedure: · day embryo biopsy

Two cell biopsy

Other group

Treatment:

Procedure: Biopsy of Day 3 Embryo