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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.

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

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

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

Increases accessibility for a wider population of patients.

Are you interested?

Request information Or email us at infousa@igenomix.com
Overview

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.

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  • Benefits
  • Indications

What is EMBRACE?

  • 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.
  • 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?

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.

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.

Rubio C, Navarro-Sánchez L, García-Pascual CM, Ocali O, Cimadomo D, Venier W, Barroso G, Kopcow L, Bahçeci M, Roos Kulmann ML, López L, De la Fuente E, Navarro R, Valbuena D, Sakkas D, Rienzi, Simón. Multicenter prospective study of concordance between embryo cell-free DNA and trophectoderm biopsies from 1,301 human blastocysts. American Journal of Obstetric and Gynecology.

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We work to make a world in which infertility is no longer an impossible barrier. Together with clinics and fertility doctors worldwide we investigate human reproduction to change the lives of couples who are trying to conceive.

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