ERA® Endometrial Receptivity Analysis

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Overview

ERA
Benefits
Indications

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.
ERA is the first test to determine each woman’s unique personalised embryo transfer timing, aiming to synchronise the embryou transfer with the personal window of implantation.

ERA RCT Conclusions

What is the procedure?

Why use ERA test?

Our randomised study* confirms that personalising embryo transfer according to the patient’s window of implantation achieves better results than a standard-timing transfer.
56.2% live birth rate in the first embryo transfer*.
This molecular diagnostic tool uses NGS to analyze the expression level of 248 genes related to the status of endometrial receptivity.
ERA is supported by 21 publications; 13 from Igenomix and 8 external publications.
Proprietary algorithm based on machine learning that minimises the need for second biopsy (90% of cases).
Allows clinicians to identify transition phases with 12 hours shifts.

*Simón et al. A 5-year Multicenter Randomized Controlled Trial of In Vitro Fertilization with Personalized Blastocyst Transfer versus Frozen or Fresh Transfer. Reproductive BioMedicine Online (2020). DOI:10.1016/j.rbmo.2020.06.002

**Ruiz-Alonso et al., The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertility and Sterility, 2013;100(3):818-24. 10.1016/j.fertnstert.2013.05.004.

Who should use ERA test?

Indicated for all patients undergoing assisted reproduction treatments.
ERA has the greatest benefit for patients who have exprienced repeated implantation failures.

When should the biopsy be performed?

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” result needing 2 more days with progesterone.
Patients with a “Post-receptive” result.

Test limitations

Scientific evidence

*Simón et al., In vitro fertilization with personalized blastocyst transfer versus frozen or fresh blastocyst transfer: a multicenter, randomized clinical trial. Fertility and Sterility, 2019; 112. e56-e57. 10.1016/j.fertnstert.2019.07.273.

**Oral presentation, Clemente-Císcar, ESRHE 2018.

Relevant related studies:

Igenomix
External

A genomic diagnostic tool for human endometrial receptivity based on the transcriptomic signature.

Díaz-Gimeno P, Horcajadas JA, Martínez-Conejero JA, Esteban FJ, Alamá P, Pellicer A, Simón C.

Fertil Steril. 2011 Jan;95(1):50-60, 60.e1-15. doi: 10.1016/j.fertnstert.2010.04.063. Epub 2010 Jul 8.

PMID:20619403

The accuracy and reproducibility of the endometrial receptivity array is superior to histology as a diagnostic method for endometrial receptivity.

Díaz-Gimeno P, Ruiz-Alonso M, Blesa D, Bosch N, Martínez-Conejero JA, Alamá P, Garrido N, Pellicer A, Simón C.

Fertil Steril. 2013 Feb;99(2):508-17. doi: 10.1016/j.fertnstert.2012.09.046. Epub 2012 Oct 23.

PMID:23102856

The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure.

Ruiz-Alonso M, Blesa D, Díaz-Gimeno P, Gómez E, Fernández-Sánchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simón C.

Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.

PMID:23756099

The impact of using the combined oral contraceptive pill for cycle scheduling on gene expression related to endometrial receptivity.

Bermejo A, Iglesias C, Ruiz-Alonso M, Blesa D, Simón C, Pellicer A, García-Velasco J.

Hum Reprod. 2014 Jun;29(6):1271-8. doi: 10.1093/humrep/deu065. Epub 2014 Apr 4.

PMID:24706003

What a difference two days make: “personalized” embryo transfer (pET) paradigm: a case report and pilot study.

Ruiz-Alonso M, Galindo N, Pellicer A, Simón C.

Hum Reprod. 2014 Jun;29(6):1244-7. doi: 10.1093/humrep/deu070. Epub 2014 Apr 15.

PMID:24737781

Timing the window of implantation by nucleolar channel system prevalence matches the accuracy of the endometrial receptivity array.

Nejat EJ, Ruiz-Alonso M, Simón C, Meier UT.

Fertil Steril. 2014 Nov;102(5):1477-81. doi: 10.1016/j.fertnstert.2014.07.1254. Epub 2014 Sep 17.

PMID25241377

Impact of final oocyte maturation using gonadotropin-releasing hormone agonist triggering and different luteal support protocols on endometrial gene expression.

Bermejo A, Cerrillo M, Ruiz-Alonso M, Blesa D, Simón C, Pellicer A, Garcia-Velasco JA.

Fertil Steril. 2014 Jan;101(1):138-146.e3. doi: 10.1016/j.fertnstert.2013.09.033. Epub 2013 Oct 29.

PMID:24182413

Is endometrial receptivity transcriptomics affected in women with endometriosis? A pilot study.

Garcia-Velasco JA, Fassbender A, Ruiz-Alonso M, Blesa D, D’Hooghe T, Simon C.

Reprod Biomed Online. 2015 Nov;31(5):647-54. doi: 10.1016/j.rbmo.2015.07.014. Epub 2015 Aug 11.

PMID:26385059

Intrauterine human chorionic gonadotropin infusion in oocyte donors promotes endometrial synchrony and induction of early decidual markers for stromal survival: a randomized clinical trial.

Strug MR, Su R, Young JE, Dodds WG, Shavell VI, Díaz-Gimeno P, Ruíz-Alonso M, Simón C, Lessey BA, Leach RE, Fazleabas AT.

Hum Reprod. 2016 Jul;31(7):1552-61. doi: 10.1093/humrep/dew080. Epub 2016 Apr 26.

PMID:27122490

Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis.

Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB.

Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.

PMID:27919438

Window of implantation transcriptomic stratification reveals different endometrial subsignatures associated with live birth and biochemical pregnancy.

Díaz-Gimeno P, Ruiz-Alonso M, Sebastian-Leon P, Pellicer A, Valbuena D, Simón C.

Fertil Steril. 2017 Oct;108(4):703-710.e3. doi: 10.1016/j.fertnstert.2017.07.007. Epub 2017 Aug 30.

PMID:28863933

Inter-cycle consistency versus test compliance in endometrial receptivity analysis test.

Stankewicz T, Valbuena D, Ruiz-Alonso M.

J Assist Reprod Genet. 2018 May 26. doi: 10.1007/s10815-018-1212-7

Effect of mifepristone on the transcriptomic signature of endometrial receptivity.

von Grothusen C, Lalitkumar PG, Ruiz-Alonso M, Boggavarapu NR, Navarro R, Miravet-Valenciano J, Gemzell-Danielsson K, Simon C.

Hum Reprod. 2018 Aug 22. doi: 10.1093/humrep/dey272. [Epub ahead of print] PMID: 30137464

Live birth after embryo transfer in an unresponsive thin endometrium.

Cruz, J. Bellver.

Gynecol Endocrinol. 2014 Jul;30(7):481-4. doi: 10.3109/09513590.2014.900747. Epub 2014 Mar 20.

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

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

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.

PMID:29327111

The Reproductive Outcomes for the Infertile Patients with Recurrent Implantation Failures May Be Improved by Endometrial Receptivity Array Test.

Ota, T., Funabiki, M., Tada, Y., Karita, M., Hayashi, T., Maeda, K. et al.

Journal of Medical Cases. 2019; 10(5), 138-140. doi: https://doi.org/10.14740/jmc3282

Why results of endometrial receptivity assay testing should not be discounted in recurrent implantation failure?
Simrandeep K., Padmaja N. The Onco Fertility Journal. 2019; 2(1): 46-49.

Personalized Embryo Transfer Helps in Improving In vitro Fertilization/ICSI Outcomes in Patients with Recurrent Implantation Failure.

Patel JA, Patel AJ, Banker JM, Shah SI, Banker MR. J Hum Reprod Sci. 2019; 12(1):59-66. doi: 10.4103/jhrs.JHRS_74_18.

Endometrial Receptivity Analysis – a tool to increase an implantation rate in assisted reproduction.

Hromadová L; Tokareva I; Veselá K; Trávník P; Veselý J. Ceska Gynekol. 2019; 84(3): 177-183.