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NCT03530254 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Igenomix.

Terminated
Registry status
NA
Development phase
368
Enrollment target

NCT03530254: Clinical Trial NA study, sponsored by Igenomix.

NCT03530254 is a NA study that was terminated before completion, run by Igenomix. The registered enrollment target is 368 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03530254, a NA study, was terminated before completion, sponsored by Igenomix.

TERMINATED
Registry status
NA
Development phase
368 participants
Enrollment target

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.

Primary Outcome

Number of babies born per embryo transfer

Interventions

  • DIAGNOSTIC_TEST PGT-A
  • DIAGNOSTIC_TEST ERA Test

Trial Details

FieldValue
Enrollment Target 368 participants
Start Date 2018-05-28
Est. Completion 2022-02-22
Phase NA
Igenomix

4 total trials

Why NCT03530254 stopped before completion

NCT03530254 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 2 interventions - of which PGT-A is the first listed.

NCT03530254 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03530254 about?

NCT03530254 is a clinical study titled "Clinical Study of PGT-A Versus PGT-A+ERA". 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...

What is the current status of trial NCT03530254?

This trial is currently terminated. It is a NA study. The enrollment target is 368 participants. The study started on 2018-05-28. Estimated completion is 2022-02-22.

What interventions are being tested in trial NCT03530254?

The interventions under investigation include: PGT-A (DIAGNOSTIC_TEST), ERA Test (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03530254?

This trial is sponsored by Igenomix, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03530254's enrollment target sits among peer trials

368 283rd of 2000 higher than 1,717 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03530254, the US trial registry maintained by the National Library of Medicine. NCT03530254 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.