Recruiting

ERA® Test

Sponsor:

Igenomix

Code:

NCT06097559

Conditions

Infertility of Uterine Origin

Implantation Failure

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Accepted

Interventions

Endometrial fluid and biopsy collection

Endometrial fluid and biopsy collection

Study Details

Brief 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

Study ID

NCT06097559

Start date

Jan 16, 2024

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Study ICF signature.
  • Female age between 18 and 41 years (both included).
  • IVF/ICSI (own or donated gametes) patients with ≥1 previous failed euploid/low-range mosaic embryo transfer(s) or ≥2 previous failed transfers with non-tested good quality embryos. (ROPA method is allowed).
  • ≥1 PGT-A tested euploid/low-range mosaic blastocyst (day 5/6) available to be transferred (SET or DET according to medical recommendation).
  • BMI 18.0 - 30.0 Kg/m2.
  • Negative serological tests for HIV, HBV, HCV, RPR.

Exclusion Criteria:

  • 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).
  • Active endometritis and salpingitis at the moment of the inclusion.
  • 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.

Study Design

Enrollment

738 participants

Anticipated

Interventions and Outcome Measures

Arms

Clinical Outcomes in a Receptive Endometrium

Enrolled patients that according to the ERA® report are receptive.

The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid.

No drugs will be administered as per the study.

Clinical Outcomes in a Non-receptive Endometrium

Enrolled patients that according to the ERA® report have a displaced WOI and are non-receptive.

The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid.

No drugs will be administered as per the study.

Interventions

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.

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.

Primary outcome measure

  • Refinement of the ERA® computational analysis [ Time Frame: At least 12 gestational weeks ]

Central Contacts and Locations

Central contacts

Carlos Gomez, BSc MSc

+34963905310carlos.gomez@igenomix.com

Diana Valbuena, MD, PhD

+34963905310diana.valbuena@igenomix.com

Locations

Arizona Center for Fertility Studies

Recruiting

Phoenix, Arizona, United States, 85260

Contacts

Shane Lipskind, MD, PhD

(+1) 480-860-4792shane@acfs2000.com

More Information

Sponsor

Igenomix

Last update posted

Dec 31, 2024

Last verified

Dec, 2024

Keywords

  • Infertility
  • Implantation failure
  • Uterine microbiome
  • Preimplantational Genetic Testing for Aneuploidies
  • Endometrial factor
  • Window of implantation
  • Endometrial receptivity
  • Personalized embryo transfer
  • Frozen embryo transfer
  • Endometrial Receptivity Analysis (ERA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Igenomix on 2024-12-31.