Blastomere Biopsy Safety Clinical Trial
Official title:
Effects of the Blastomere Biopsy of Day 3 Human Embryos on Blastocyst Percentage, Cell Number of Obtained Blastocyst and Implantation Rate
The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and implantation rate.
Preimplantation genetic diagnosis (PGD) was initially developed to prevent monogenic
diseases. However, its use has been extended to improve pregnancy rates in assisted
reproductive techniques (ART). These new indications has been called screening for
aneuploidy (PGS, preimplantation genetic screening). The current indications for PGS include
advanced maternal age, recurrent miscarriage, repeated implantation failure, severe male
factor infertility, previous aneuploid pregnancy, poor embryo quality, chemotherapy and
radiotherapy and elective single embryo transfer to avoid multiple pregnancies.
Nevertheless, the results obtained in the last decade have failed to clearly demonstrate any
benefit of PGS in these indications and there are no studies evaluating the effect that
biopsy could produce on embryos.
Markers of embryo quality are still very limited and are based on subjective morphological
parameters (such as cell number, size and degree of fragmentation) or on the study of
embryonic development by measuring the percentage of embryos reaching the blastocyst stage
after 120 hours of in vitro culture. Counting the cell number of blastocysts involves the
staining and subsequent nuclei counting, which is incompatible with later embryo transfer. A
valid alternative to avoid nuclear staining would be a morphometric study using optical
sections of different focal planes of the blastocyst and three dimensional (3D) virtual
reconstructions.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic