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Genetic Solutions > EMBRACE

EMBRACE: Embryo Analysis of Culture Environment

A non-invasive test for prioritizing embryo transfer that avoids invasive embryo biopsy, potentially increasing accessibility for a wider patient population.

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  • Technical overview
  • Documentation
  • Scientific evidence
  • I’m not a health specialist

A non-invasive solution for patients leading to more efficient IVF treatment.

Embrace

Avoids embryo biopsy by analyzing cell-free DNA in spent culture medium.

SAT Sperm aneuploidy test

Increases accessibility for a wider population of patients.

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Overview
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  • Benefits
  • Indications

What is EMBRACE test?

  • EMBRACE is a non-invasive test for prioritizing embryo transfer that avoids invasive embryo biopsy, thereby potentially increasing accessibility for a wider patient population.
  • EMBRACE scores embryos according to their probability of being healthy and viable based on chromosomal information.
  • The recent identification of embryo cell-free DNA in spent blastocyst media opened a new era of possibilities for non-invasive embryo aneuploidy testing in assisted reproductive technologies.
  • During in-vitro embryo development, embryo cell-free DNA is released into the culture medium, with higher concentrations as the number of cells increases at blastocyst stage.

  • Spent blastocyst medium containing the embryo cell-free DNA can be analyzed by next generation sequencing (NGS), representing a non-invasive approach to estimate the chromosome copy number of the blastocyst without the need for trophectoderm biopsy.

What is the procedure?

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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.

Scientific Evidence

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.
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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.

Publications

Who should use EMBRACE?

  • Any patients who wish to increase their chances of pregnancy without an invasive embryo biopsy.

Test limitations and considerations:

  • 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.
Documentation

Clinical Sheets

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Brochure

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Scientific evidence

Vera-Rodriguez M, Diez-Juan A, Jimenez-Almazan J, Martinez S, Navarro R, Peinado V, Mercader A, Meseguer M, Blesa D, Moreno I, Valbuena D, Rubio C, Simón C. Origin and composition of cell-free DNA in spent medium from human embryo culture during preimplantation development. Hum Reprod. 2018 Apr 1;33(4):745-756. doi: 10.1093/humrep/dey028. PubMed PMID: 29471395.

Rubio C, Rienzi L, Navarro-Sánchez L, Cimadomo D, García-Pascual CM, Albricci L, Soscia D, Valbuena D, Capalbo A, Ubaldi F, Simón C. Embryonic cell-free DNA versus trophectoderm biopsy for aneuploidy testing: concordance rate and clinical implications. Fertil Steril. 2019 Sep;112(3):510-519. doi:10.1016/j.fertnstert.2019.04.038. Epub 2019 Jun 11. PubMed PMID: 31200971.

Carmen Rubio, Luis Navarro-Sánchez, Carmen M. García-Pascual,…Denny Sakkas, Laura Rienzi, & Carlos Simón. Multicenter prospective study of concordance between embryo cell-free DNA and trophectoderm biopsies from 1,301 human blastocysts. American Journal of Obstetrics and Gynecology. First published version available online: 26-MAY-2020 DOI information: 10.1016/j.ajog.2020.04.035.

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