RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-16
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06097559

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.

Ages Eligible for Study:18 Years to 37 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study ICF signature.
  2. * Female age between 18 and 37 years (both included).
  3. * IVF/ICSI patients with ≥1 previous failed euploid embryo transfer(s) or ≥2 previous failed transfers with non-tested good quality embryos.
  4. * Blastocyst tested by PGT-A.
  5. * BMI 18.0 - 30.0 Kg/m2.
  6. * 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.
  7. * Negative serological tests for HIV, HBV, HCV, RPR.
  1. * No euploid/low-range mosaic blastocysts (day 5/6), from own or donated gametes, for a FET. Notes:
  2. * Only one COS and PGT-A will be allowed per patient.
  3. * 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.
  4. * Reception of Oocytes from Partner -ROPA- method is allowed.
  5. * Double embryo transfer is allowed by medical indication as long as both blastocysts are transferred at once.
  6. * No HRT in the biopsy and/or the embryo transfer cycle.
  7. * Intrauterine device (IUD) carriers within 3 months before sample collection.
  8. * Surrogate pregnancy (in those countries where it is allowed).
  9. * 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).
  10. * Recurrent Pregnancy Loss (RPL ≥2 previous intrauterine miscarriages).
  11. * Endometritis and salpingitis.
  12. * Endometriosis stage \> I (stages II, III and IV) according to ASRM classification.
  13. * Atrophic endometrium (\< 6 mm) in the ERA® and/or embryo transfer cycle.
  14. * Endometrial receptivity test and/or microbiome test done before ICF signature.
  15. * Preimplantation Genetic Testing for Chromosomal Structural Rearrangements (PGT-SR) or Preimplantation Genetic Testing for Monogenic Disorders (PGT-M) concomitant indications.
  16. * DuoStim IVF protocol (double ovarian stimulation and two egg retrievals in the same ovarian cycle).
  17. * 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.

Contacts and Locations

Study Contact

Carlos Gomez, BSc MSc
CONTACT
+34963905310
carlos.gomez@igenomix.com
Diana Valbuena, MD, PhD
CONTACT
+34963905310
diana.valbuena@igenomix.com

Principal Investigator

Maria Ruiz, MSc
PRINCIPAL_INVESTIGATOR
Igenomix

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Igenomix

  • Maria Ruiz, MSc, PRINCIPAL_INVESTIGATOR, Igenomix

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-16
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-01-16
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

  • Infertility of Uterine Origin
  • Implantation Failure