New Hope Center for Reproductive Medicine

ERA

PATIENT SERVICES AT NEW HOPE CENTER FOR REPRODUCTIVE MEDICINE

ERA (Endometrial Receptivity Analysis)

Evaluates the status of the woman’s endometrial receptivity to prevent implantation failure

Overview

  • ERA is a diagnostic test patented by IGENOMIX in 2009 that helps to evaluate the woman’s endometrial receptivity.
  • ERA identifies a patient’s unique “window of implantation” (WOI) leading to a personalized embryo transfer (pET).
  • 3 in every 10 patients have a displaced WOI. In such cases, a second endometrial biopsy is needed to identify when the patient is receptive.

Benefits

  • ERA identifies the window of implantation (WOI) and recommends the best time for embryo transfer thereby increasing the chances of a successful outcome.
  • The ERA test has proven highly sensitive and accurate in detecting gene expression profiles associated with endometrial receptivity.
  • The ERA test resulted in a 73% pregnancy rate in patients with implantation failure.

Ruiz-Alonso et al, Fertil Steril. 2013
Clemente-Ciscar et al, 2018, submitted

Indications

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

Technology

The ERA test is performed with Next Generation Sequencing (NGS) technology

  • NGS is a scalable technology allowing large numbers of samples to be analyzed simultaneously.
  • NGS flexibility and accuracy has enabled the development of a new, improved predictor tool and will allow us to further enhance the test’s effectiveness and include additional diagnostic markers.

Methodology

The ERA test requires a quick and easy endometrial biopsy.

Methodology

Endometrial Receptivity Analysis (ERA)

When To Perform The Embryo Transfer

The blastocyst transfer should be performed in the same type of cycle and on the same day in which a receptive result was obtained. A receptive result indicates the ideal day on which the blastocyst transfer should be performed. A day 3 embryo should therefore be transferred 2 days earlier.

Endometrial Receptivity Analysis (ERA)

Comparison of Clinical Results

Data from a pilot study comparing Frozen Embryo Transfer (FET) to personalized Embryo Transfer (pET) in the same patient cohort. Patients underwent an FET before performing their first ERA test, on a day that was later diagnosed as non-receptive by the ERA. Patients then received a pET on their receptive day, after confirmation from a 2nd ERA biopsy.

Ruiz-Alonso et al. Human Reproduction 2014 Jun; 29(6): 1244-7

Comparison of Clinical Results

Results

Results

1: 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 analyze the expression level of 248 genes related to the status of endometrial receptivity.

To do so, RNA obtained from an endometrial tissue sample is analyzed and then classified by our ERA predictor as receptive or non-receptive, depending on the expression profile of the RNA.

2: What is the purpose of the ERA test?

The ERA test is used to evaluate the stage of an endometrium to determine if a receptive or non-receptive genetic profile is present at the time of biopsy. If the case where the endometrium is non-receptive, the test enables us to find a personalized window of implantation for each patient.

Results

3: Who should use the ERA test and why?

The ERA test has been proven to help patients who have experienced implantation failure while using good quality embryos.

4: Advantages of the ERA test

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 personalized window of implantation to be detected before the patient starts using assisted reproduction techniques. This is more sensitive than the classical method of endometrial dating, based on histological criteria, which is highly subjective and has been proven to be unable to discriminate between fertile and infertile patients.

5: Sample extraction and shipment

An endometrial biopsy taken from the uterine fundus must be immediately introduced into an ERA cryotube and stored in a refrigerator (4-8°C/ 39-46°F) for at least 4 hours.

In order to ensure the highest sample quality, we recommend that shipment to our laboratory takes less than 120 hours at room temperature. In addition, the sample should never reach more than 35°C/ 95°F.

6: Methodology

Main stages of the procedure

Results

7: Limits of the technique

The ERA test has a specificity of 0.97 and a sensitivity of 0.90 for receptivity profile classification. The biopsy procedure, though simple, has a risk (less than 5%) of not obtaining a sufficient quantity and/or quality of endometrial tissue, in which case it is impossible to perform the test and a new sample extraction is required.