ERA® 子宮內膜容受性檢測

Endometrial Receptivity Analysis

透過個人化著床窗期植入胚胎

技術概論

ERA
適應症
優點

什麼是 ERA檢測?

由Igenomix 開發並取得唯一專利權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技前，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。

檢測流程

ERA 從子宮內膜抽取樣本組織，並根據我們的 ERA 預測因子對 RNA 進行分析，然後根據 RNA 的基因表現，將其分類為 Receptive 或 Non-receptive。
如果檢測結果子宮內膜為 Non-receptive，我們能為每個患者找到個人化著床窗期。

*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？

即使植入形態上品質良好的胚胎，仍然經歷植入失敗的女性。
擁有形態上正常的子宮和正常子宮內膜厚度（≧ 6 mm）的女性，其子宮與子宮內膜較無可能是問題來源，卻還是無法懷孕者。

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。

為什麼要使用ERA檢測？

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%。

*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

科學研究

*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.

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

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

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

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

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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.

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

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

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

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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.

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

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

Effect of mifepristone on the transcriptomic signature of endometrial receptivity.

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Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study.

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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.

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

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

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

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

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