Viewing Study NCT03530254



Ignite Creation Date: 2024-05-06 @ 11:30 AM
Last Modification Date: 2024-10-26 @ 12:46 PM
Study NCT ID: NCT03530254
Status: TERMINATED
Last Update Posted: 2022-05-04
First Post: 2018-05-08

Brief Title: Clinical Study of PGT-A Versus PGT-AERA
Sponsor: Igenomix
Organization: Igenomix

Study Overview

Official Title: International Multi-center Randomized and Controlled Clinical Study to Evaluate the Clinical Benefit of the ERA Test in Infertile Patients Undergoing Assisted Reproduction Treatment and Medical Indication of PGT-A
Status: TERMINATED
Status Verified Date: 2022-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Low recruitment speed higher percentage drop-out and SARS-CoV-2 pandemic situation
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PGT-AERA
Brief 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 patients 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
Detailed Description: The lack of receptivity of the uterus and chromosomal abnormalities in the embryo are the two main causes of implantation failure Patients with implantation failure should consider the PGT-A test to identify and select euploid embryos In addition it should be evaluated the endometrium receptivity state at the time of Embryo Transfer ET

The PGT-A is an important genetic test that was developed to select embryos during IVF treatment and avoid embryonic chromosomal abnormalities that lead to miscarriage or life born with chromosomal diseases Embryonic aneuploidy is linked to maternal age The most common consequences are implantation failure miscarriage or life born with multiple congenital anomalies The transfer of euploid embryos chromosomally normal diagnosed by PGT-A has shown an increase in implantation rates

Morphology is the most traditional and routine method of embryo selection being used However it is difficult to distinguish normal and abnormal embryos by observing their morphology under a microscope Therefore morphological analysis should not be the only technique used to decide which embryo should be transferred Application of NGS in PGT-A cycles demonstrates that this methodology is reliable allowing identification and transfer of euploid embryos resulting in ongoing pregnancies However despite the transfer of morphologically normal euploid embryos it is not always possible to acquire optimal results in Assisted Reproductive Techniques ART

On the other hand the endometrial gene expression profile allows the diagnosis of the endometrium receptivity status This is carried out by a molecular tool developed and patented by Igenomix PCTES200900386 The ERA test is a customized expression microarray that identifies the transcriptomic expression profile signature of the personalized Window of Implantation pWOI A bioinformatic predictor determines the moment of maximum receptivity indicating the best time to perform a pET

If the result of the ERA test is Receptive the WOI and the moment of taking the biopsy overlap Nevertheless if the result is Pre-Receptive the optimal implantation window is expected to be after the moment in which the biopsy is taken and if the diagnosis is Post-Receptive the optimal window of implantation is prior to the biopsy In a subsequent cycle a pET will be performed according to the ERA test results

Recently it has been conducted a pilot study in patients with previous implantation failures with PGT-A and euploid embryo transfer ET The results of the ERA test have shown that a high percentage of these patients have been diagnosed as Non-receptive 90 This percentage is higher than the expected in the normal population 12-20 or in the Repeated Implantation Failure RIF patients without PGT-A 25-30 Once the pET was performed according to the results of the ERA test the gestation rate was 5555

So the objective of the present study is to validate these preliminary results in a prospective multi-center randomized and controlled study to demonstrate the value of the endometrial factor and the improvement of the results obtained in patients with PGT-A indication If confirmed it would be recommended the ERA test for all ART patients not only for those with PGT-A demonstrating the significance in searching for the pWOI to improve reproductive outcomes

Considering a maximum drop-out rate of 30 a total of 750 participants are expected to be included According to the approved protocol an interim analysis is planned at 50 of the total enrolment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None