MedTrace Logo

Clinical Study of PGT-A Versus PGT-A+ERA

NCT03530254 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2022-05-04

No results posted yet for this study

Summary

Patients who have shown previous implantation failures, despite transferring good quality and chromosomally normal embryos (diagnosed by PGT-A), could have a displaced Window of Implantation (WOI) and consequently, alterations in their endometrial receptivity. The correction of this displacement can improve the results of the Assisted Reproduction Treatments (ART).

The ERA test (Endometrial Receptivity Analysis) evaluates the transcriptomic endometrial profile to determine if the patient's uterus is receptive when the embryo is transferred during an In Vitro Fertilization (IVF) process, and identifies the personalized WOI of the patient. This process is called Personalized Embryo Transfer (pET).

The Preimplantation Genetic Test of Aneuploidies or PGT-A (Preimplantation Genetic Testing for Aneuploidy), is currently carried out using Next Generation Sequencing (NGS) and serves to identify chromosomally normal embryos prior to their transfer in an IVF treatment. Aneuploidies are rarely compatible with life or can cause congenital diseases. So, the identification of chromosomally normal embryos, improves the success of reproduction in cases in which infertility is caused by such aneuploidies.

Therefore, the aim of this study is to determine, in a randomized and prospective way, the clinical benefit of adding the ERA test to the embryonic aneuploidies test for patients with a PGT-A indication.

Conditions

  • Infertility of Uterine Origin

Interventions

DIAGNOSTIC_TEST

PGT-A

PGT-A will be carried out following the usual clinical practice. Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.

DIAGNOSTIC_TEST

ERA Test

The ERA test requires an endometrial biopsy and will determine if the endometrium is receptive or not by analysing the expression levels of 236 genes involved in endometrial receptivity, to assess the optimal time to place an embryo into the uterus and promote a successful implantation and pregnancy.

Sponsors & Collaborators

  • Igenomix

    lead INDUSTRY

Principal Investigators

  • Carlos Simón, MD PhD · Igenomix

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2022-02-22
Completion
2022-02-22

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Georgia
  • India
  • Mexico
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530254 on ClinicalTrials.gov