TerminatedNot Applicable

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

Stopped: Low recruitment speed, higher percentage drop-out and SARS-CoV-2 pandemic situation

United States, Argentina, Brazil368 participantsStarted 2018-05-28

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Majority of age patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. * Patients who already have frozen euploid blastocysts (day 5/6 development) analysed by PGT-A. * Patients with embryos obtained from their own oocytes fertilized by Intracytoplasmic Sperm Injection (ICSI) or In vitro fertilization (IVF). * Patients with an expected embryo transfer of one or two embryos (Single ET or Double ET) in a HRT cycle. * Body Mass Index: 18,5-30 Kg/m2. Exclusion Criteria: * Presence of pathologies or malformations that affect the uterine cavity such as polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx during the patient's participation in the study. Patients suffering these pathologies before or after their inclusion in the study are allowed to participate if the pathology is corrected before performing any study procedure. * 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.

What they're measuring

Live birth rate

Timeframe: 40 weeks

Trial details

NCT IDNCT03530254

SponsorIgenomix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-22

View on ClinicalTrials.gov More Infertility of Uterine Origin trials

Plain-language summary

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.