International Non-selection Study for ERA® Test in Patients With Previous Implantation Failures

Summary

Women´s period comprises different hormonal stages, being one of them the stage for maximum receptivity and proper embryo implantation. This stage is named window of implantation (WOI), and is characterized by a specific molecular pattern than can be assessed by the Endometrial Receptivity Analysis (ERA® test), developed by Igenomix. Determining the WOI allows to schedule a personalized embryo transfer (pET) when the endometrium is most receptive for the implantation.

The main objective of the present study is to improve our knowledge on the endometrial factor in an infertile population with previous implantation failures. To do so, a diagnosis of the endometrial receptivity to determine the WOI (ERA®) and the microbiome (EMMA®) of each participant will be performed, assessing its impact on deferred embryo transfers in terms of reproductive outcomes.

Participants will follow their previously programmed IVF/ICSI treatment and, only when one embryo with no major anomalies is reported by PGT-A (Preimplantation Genetic Testing for Aneuploidies), they will be asked to attend to the specific study visit for endometrial fluid and biopsy samples collection. These samples will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor, being only used for the study purpose. After this visit, the patient will follow the pre-established schedule for an embryo transfer and pregnancy assessment.

Conditions

• Infertility of Uterine Origin
• Implantation Failure

Interventions

DIAGNOSTIC_TEST

Endometrial fluid and biopsy collection

The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration) in a HRT cycle, according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy. Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice. Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET.

DIAGNOSTIC_TEST

Endometrial fluid and biopsy collection

The ERA and EMMA test require an endometrial biopsy to be taken at P+5 (after 120±6 hours of exogenous progesterone administration), according to the common clinical practice. On the same day, a sample of endometrial fluid will be aspirated immediately prior to the biopsy. Regardless of the endometrial receptivity profile, a subsequent regular FET will be performed within the standard WOI (after 120±6 hours of progesterone exposure) in an HRT cycle following the clinical standard practice. Those patients willing to participate in the rescue phase will follow the recommendation of the ERA test for the subsequent pET. In case of a non-receptive endometrium result, a second EB sample must be collected when indicated by the ERA report. Fluid sample collection will not be repeated in these cases.

Sponsors & Collaborators

• Igenomix

  lead INDUSTRY

Principal Investigators

• Maria Ruiz, MSc · Igenomix

Eligibility

Min Age

18 Years

Max Age

41 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-16

Primary Completion

2026-04-30

Completion

2026-12-31

Countries

• Argentina
• Panama
• Peru
• Spain

Study Locations