Genetic Solutions > ERA®子宮內膜容受性檢測

ERA® 子宮內膜容受性檢測

透過個人化著床窗期植入胚胎

技術概論

ERA
優點
適應症

什麼是ERA檢測?

由Igenomix 開發並取得唯一專利權 (PCT/ ES2009/000386) 的子宮內膜容受性檢測（ERA）是專為子宮內膜容受性所設計的檢測。

這項技術是利用NGS分析248個與子宮內膜容受性狀態有關的基因表現。

已有多項研究證實ERA 檢測在偵測與容受性有關的基因表現圖譜，具有高靈敏度和特異性。利用ERA檢測，可在患者進行人工生殖前，檢測其個人著床窗期。

進行ERA時，Igenomix 特有的AI演算法會先分析取自子宮內膜組織樣本的RNA，依RNA表現圖譜，再將其分類為容受性或非容受性。

若子宮內膜結果是非容受性，ERA檢測能夠找出專屬每一位患者的個人著床窗期。

ERA隨機採樣結果

根據我們的隨機抽樣研究，我們發現患者處於容受性（receptive）狀態進行胚胎植入，會比在標準時間植入有更好的成效。

檢測流程

*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

為什麼要使用ERA檢測呢?

共有21篇發表論文可支持ERA 檢測；其中13篇出自Igenomix 內部論文，另外有8篇為獨立研究。
在Igenomix 開發的專用AI演算法下，有90%的個案不需進行二次採樣。
隨機臨床試驗（NCT01954758) RCT 案證實，比起第一次即接受新鮮囊胚植入的患者，使用ERA檢測後持續懷孕率可上升25%。
15個日曆天可以得到報告。

*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

誰應該接受ERA檢測呢？

既使植入型態上品質良好的胚胎且內膜厚度≥6mm，仍經歷植入失敗的女性。
想提高懷孕機率的女性。

什麼時候會需要二次採樣呢？

90%的個案不需要二次採樣。只有在下列情形發生時，才會需要二次採樣：

Pre-receptive 2 days 結果的患者。
Post-receptive結果的患者。

檢測限制

仍有小於 5% 的機率在第一次進行ERA時，會因為檢體量、或檢體品質不足而得到無訊息的結果。如果發生這種情況，則需要進行第二次採檢。

醫師可使用 ERA 的檢測結果來進行個人化窗期植入。

不良的胚胎品質、基因異常、或個人病理情況，均可能影響懷孕的可能性。

ERA檢測並不會對任何其他子宮內膜病理提供報告，也不會評估或預測持續妊娠的健康狀況。

科學證據

*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

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.