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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Multicenter, Prospective, Non-selection Study for Endometrial Receptivity Analysis Test in Patients With Previous Implantation Failures

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

Condition
Infertility of Uterine Origin
Intervention / Treatment

-

Contacts and Locations

Phoenix

Arizona Center for Fertility Studies, Phoenix, Arizona, United States, 85260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Study ICF signature.
  • * Female age between 18 and 37 years (both included).
  • * IVF/ICSI patients with ≥1 previous failed euploid embryo transfer(s) or ≥2 previous failed transfers with non-tested good quality embryos.
  • * Blastocyst tested by PGT-A.
  • * BMI 18.0 - 30.0 Kg/m2.
  • * Normal ovarian reserve (Antral Follicle Count, AFC ≥ 8, Anti-Müllerian Hormone, AMH ≥ 1.0 ng/ml and/or Follicle-Stimulating Hormone, FSH ≤ 8 mU/mL) before starting the Controlled Ovarian Stimulation (COS) cycle.
  • * Negative serological tests for HIV, HBV, HCV, RPR.
  • * No euploid/low-range mosaic blastocysts (day 5/6), from own or donated gametes, for a FET. Notes:
  • * Only one COS and PGT-A will be allowed per patient.
  • * Low-range mosaic embryos (\< 50% of mosaic cells) could be considered for transfer following the international recommendations (ASRM and ESHRE) and the clinical standard routine at the participant center.
  • * Reception of Oocytes from Partner -ROPA- method is allowed.
  • * Double embryo transfer is allowed by medical indication as long as both blastocysts are transferred at once.
  • * No HRT in the biopsy and/or the embryo transfer cycle.
  • * Intrauterine device (IUD) carriers within 3 months before sample collection.
  • * Surrogate pregnancy (in those countries where it is allowed).
  • * Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx. (Note: Patients are allowed to participate if the pathology is previously operated at least 3 months before the endometrial samples are obtained).
  • * Recurrent Pregnancy Loss (RPL ≥2 previous intrauterine miscarriages).
  • * Endometritis and salpingitis.
  • * Endometriosis stage \> I (stages II, III and IV) according to ASRM classification.
  • * Atrophic endometrium (\< 6 mm) in the ERA® and/or embryo transfer cycle.
  • * Endometrial receptivity test and/or microbiome test done before ICF signature.
  • * Preimplantation Genetic Testing for Chromosomal Structural Rearrangements (PGT-SR) or Preimplantation Genetic Testing for Monogenic Disorders (PGT-M) concomitant indications.
  • * DuoStim IVF protocol (double ovarian stimulation and two egg retrievals in the same ovarian cycle).
  • * Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.

Ages Eligible for Study

18 Years to 37 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Igenomix,

Maria Ruiz, MSc, PRINCIPAL_INVESTIGATOR, Igenomix

Study Record Dates

2026-12