EMBRACE: Embryo Analysis of Culture Environment

Why use EMBRACE test?

• It avoids embryo biopsies and therefore reduces costs, making it accessible to a greater number of people.
• A non-invasive solution for patients, leading to a more efficient IVF treatment.

This new test is based on our recent study ‘Multicenter prospective study of concordance between embryo cell-free DNA and trophectoderm biopsies from 1,301 human blastocysts’ published in AJOG.

• This is the largest study to date assessing ploidy concordance per embryo between invasive and non-invasive PGT-A.
• The study had two main goals:
  1. To evaluate the concordance and reproducibility of testing embryo cell-free DNA versus trophectoderm DNA obtained from the same embryo in a large sample of day 6 and day 7 blastocysts.
  2. To assess the concordance rates with the inner cell mass of the blastocyst in a subset of blastocysts donated for research.
• Without any previous manipulation of the embryo, this is the only available protocol that is truly non-invasive. Previous assisted hatching, biopsy or vitrification was not permitted before media collection.
• Embryo cell-free DNA analysis shows high reliability in a multicentre study involving different culture and clinical conditions including: patient clinical backgrounds, ovarian stimulation protocols, culture media, incubators and embryo quality.

The concordance rate was on average 78.2% (ranging from 72.5% to 86.3% in different centres), with no significant differences between centers related to culture conditions or blastocyst quality.

Additionally, in a subgroup of 81 blastocysts, comparison of the inner cell mass (ICM) with the embryo cell-free DNA in spent blastocyst medium (SBM) and the trophectoderm (TE) biopsies has shown similar concordance rates, 84.4% and 87.5% respectively.

• Currently, the concordance rate of this test with invasive biopsy procedures is 78.2%, though there is no guarantee that results from embryo biopsy are always correct. This data is from ongoing clinical trials currently in progress at Igenomix.
• The test is valid only when embryos have been grown to day 6 or 7 and are at the blastocyst stage.
• This test cannot be used to determine the sex of the embryo.
• On rare occasions, genetic testing cannot be carried out because of insufficient DNA in the culture media or poor-quality DNA.
• In some cases, additional genetic assessment may be needed, which might include an embryo biopsy.