EMBRACE - United Kingdom

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Overview

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What is EMBRACE?

EMBRACE is a non-invasive test to prioritise embryos for transfer that avoids invasive embryo biopsy; potentially increasing accessibility for a wider patient population.
EMBRACE scores embryos according to their probability of being healthy (euploid) and viable based on chromosomal analysis.
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 cell-free DNA from the embryo can be analyzed using 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 biopsy costs, making it accessible to a greater number of people.
It does not require biopsy-trained embryologists, removing a barrier to offering aneuploidy analysis.
A non-invasive solution for patients, giving them peace of mind and more effective 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 aims – 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, and to assess the concordance rates with the inner cell mass of the blastocyst in a subset of blastocysts donated for research.
It is the only truly non-invasive protocol, without any previous manipulation of the embryo. No previous assisted hatching, biopsy or vitrification was permitted before media collection.
Embryo cell-free DNA analysis shows high reliability in a multicentre study involving different culture and clinical conditions including: different 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 between-centre differences related to culture conditions or blastocyst quality.

In addition, 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 using invasive biopsy procedures.

Test limitations and considerations:

Currently, the concordance rate of this test with invasive biopsy procedures is 78.2%. Concordance means the chance that the non-invasive test results match with the results of embryo biopsy, though there is no guarantee that results from embryo biopsy are always correct. These data are from ongoing clinical trials currently in progress at Igenomix.
The embryos never leave your clinic; the genetics laboratory only receives a sample of the culture medium in which the embryos have been grown. This liquid is considered waste and always disposed of once treatment has finished.
The test is valid only when embryos have been grown to 6 or 7 days of age and are at the blastocyst stage.
This test cannot be used to determine the gender 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 Sheet

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Patient Brochure

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Scientific evidence

Title: Origin and composition of cell-free DNA in spent medium from human embryo culture during preimplantation development.

Authors: 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.

Publication: Hum Reprod. 2018 Apr 1;33(4):745-756. doi: 10.1093/humrep/dey028.

PMID: 29471395

Title: Embryonic cell-free DNA versus trophectoderm biopsy for aneuploidy testing: concordance rate and clinical implications.

Authors: Rubio C, Rienzi L, Navarro-Sánchez L, Cimadomo D, García-Pascual CM, Albricci L, Soscia D, Valbuena D, Capalbo A, Ubaldi F, Simón C.

Publication: Fertil Steril. 2019 Sep;112(3):510-519. doi:10.1016/j.fertnstert.2019.04.038. Epub 2019 Jun 11.

PubMed PMID: 31200971

Title: Multicenter prospective study of concordance between embryo cell-free DNA and trophectoderm biopsies from 1,301 human blastocysts.

Authors: 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.

Publication: Am J Obstet Gynecol. 2020 Nov;223(5):751.e1-751.e13. doi: 10.1016/j.ajog.2020.04.035. Epub 2020 May 26.

PMID: 32470458

Igenomix and fertility

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