ERA - Middle East

Overview

ERA
Indications
Benefits

What is the ERA test?

The Endometrial Receptivity Analysis (ERA), developed and patented by Igenomix (PCT/ ES2009/000386), is a test designed to evaluate endometrial receptivity.
This molecular diagnostic tool uses NGS to analyse the expression level of 248 genes related to the status of endometrial receptivity.

The ERA test has been shown to be highly sensitive and specific in the detection of genetic expression profiles associated with receptivity. It allows the personalised window of implantation to be detected before the patient starts using assisted reproduction techniques.
To do so, RNA obtained from an endometrial tissue sample is analysed and the endometrial receptivity profile is classified by our ERA predictor.
The high-resolution of ERA enables us to designate the endometrium across the spectrum of pre-receptive – early-receptive – receptive – late-receptive – post-receptive. This detailed identification of a patient’s personalised window of implantation allows us to recommend a precise (+/- 3 hours) timing for embryo transfer.

What is the procedure?

Who should use ERA test?

Women who have experienced implantation failure with morphologically good quality embryos
Women with a morphologically normal uterus and normal endometrial thickness (≥ 6 mm), where the structure of the uterus and endometrium are unlikely to be the problem.

When is the second endometrial biopsy needed?

90 % of cases don’t need a second biopsy. The second biopsy is only required under two circumstances:

Patients with a “Pre-receptive 2 days” result
Patients with a “Post-receptive” result

Test limitations

There is a risk (<5%) of a non-informative result when the biopsy procedure has failed to obtain a sufficient quantity and/or quality of tissue to be able to make a diagnosis. If this should occur a new biopsy will be required.
The aim of this test Is to provide physicians with an objective molecular diagnosis of the patient’s endometrial receptivity window. Depending on the results of this test, the physician may use it as a guide for a personalised embryo transfer.
Pregnancy is not guaranteed, even with a receptive result. Poor embryo quality, genetic abnormalities, or previous pathologies can also reduce the likelihood of becoming pregnant.
ERA® does not test for any other endometrial pathology and does not asses or provide a prediction for the health of a subsequent pregnancy.

Why use ERA test?

ERA is backed by 33 publications; 29 from Igenomix and 4 external publications.
Randomized clinical trial (NCT01954758) RCT proves Cum. Pregnancy rate increases +22 points VS classic fresh blastocyst transfer in first appointment patients:
Proprietary algorithm based on machine learning that minimises the need for a second biopsy to only 10% of cases

Documentation

ERA Specialist's documents

The development of the ERA diagnostic tool was published in the paper by Díaz-Gimeno et al, 2011 (Fertil Steril. 2013 Feb; 99(2):508-17).

ERA´s effectiveness and consistency were demonstrated in the paper by Díaz-Gimeno et al, 2013 (Fertil Steril. 2013 Feb; 99 (2): 508-17).

ERA clinical applicability to patients with implantations failure was demonstrated in a publication by Ruiz-Alonso et al, 2013 and 2014.

What a difference two days make: “personalized” embryo transfer (pET) paradigm: a case report and pilot study Ruiz-Alonso M. et al, 2014. (Hum Reprod. 2014 Jun;29(6):1244-7)

A randomized study is currently in progress to assess its applicability to patients without any prior assisted reproduction treatment (ClinicalTrials.gov Identifier: NCT01954758).

The role of the endometrial receptivity array (ERA) in patients who have failed euploid embryo transfers. Tan J, Kan A, Hitkari J, Taylor B, Tallon N, Warraich G, Yuzpe A, Nakhuda G. J Assist Reprod Genet. 2018 Jan 11. doi: 10.1007/s10815-017-1112-2. [Epub ahead of print]

Combinatorial use of Endometrial Receptivity Array (ERA) and PGT-A can improve the clinical outcome in cases with previous ART failures. N. Findikli, M. Gultomruk, K. Boynukalin, M. Kavrut, E. Oral, M. Bahceci. ESHRE Oral communication.

Pregnancy outcomes in patients undergoing embryo transfer in cycle following endometrial receptivity assay. M. Pasternak, G. Schattman, Z. Rosenwaks. ASRM Poster.

The implantation rate of Japanese infertile patients with repeated implantation failure can be improved by endometrial receptivity array (ERA) test: A randomized controlled trial. S. Taguchi, M. Funabiki, T. Hayashi, Y. Tada, Y. Iwaki, M. Karita, T. Ota, K. Maeda, T. Matsubara, P. Zada, N. Sugiyama, Y. Nakamura. ASRM Oral communication.

Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul. PMID:29259480

Assessment of endometrial receptivity by endometrial receptivity array (ERA) in patients with adenomyosis and previous implantation failure in IVF. Kaur S, Mahajan N, Rani K, Naidu P, Kaur J. ESHRE Poster.

Mode of progesterone administration and its effects on endometrial receptivity in programmed frozen embryo transfer cycles. Rosen A, Huang A, Billb Y. PCRS Poster.

Endometrial Receptivity and pregnancy rates are higher after 7 days of progesterone in medicated FET cycles. A.M. Propst, L. Hansard, K. Silverberg, M. Hegtvedt, N.Z. Burger, T.C. Vaughn. ASRM Poster.

Endometrial receptivity array: Clinical application. Mahajan N. J Hum Reprod Sci. 2015 Jul-Sep;8(3):121-9. doi: 10.4103/0974-1208.165153. Review. PMID:26538853.

Live birth after embryo transfer in an unresponsive thin endometrium. F. Cruz, J. Bellver. Gynecol Endocrinol. 2014 Jul;30(7):481-4. doi: 10.3109/09513590.2014.900747. Epub 2014 Mar 20.

Mode of progesterone administration and its effects on endometrial receptivity in programmed frozen embryo transfer cycles. Rosen A, Huang A, Billb Y. PCRS Poster.

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Robust randomized clinical study results

Backed by 33 publications

30% of patients have a displaced window of implantation

55.000 patients

Are you interested?

What is the ERA test?

What is the procedure?

Who should use ERA test?

When is the second endometrial biopsy needed?

Test limitations

Why use ERA test?

Technical Sheets

Brochure

Relevant related studies:

Can we help you?

Igenomix and fertility

EndomeTRIO

EMMA

ALICE

ERA® Endometrial Receptivity Analysis

The ERA test evaluates the stage of an endometrium to determine if a receptive or non-receptive genetic profile is present at the time of biopsy.

Robust randomized clinical study results

Backed by 33 publications

30% of patients have a displaced window of implantation

55.000 patients

Are you interested?

What is the ERA test?

What is the procedure?

Who should use ERA test?

When is the second endometrial biopsy needed?

Test limitations

Why use ERA test?

Technical Sheets

Brochure

Relevant related studies:

Can we help you?

Igenomix and fertility

Other services you may be interested

EndomeTRIO

EMMA

ALICE

Igenomix is in the media