NCT04000152: niPGT-A_RCT

RCT Study to Validate niPGT-A Clinical Benefit.

Terminated NA Last updated 1 October 2025

What this trial tests

NA trial testing niPGT-A in Aneuploidy in 296 participants. Terminated before completion.

Timeline

29 June 2020

Primary endpoint
18 April 2025

18 April 2025

Quick facts

Lead sponsor	Igenomix
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	296
Start date	29 June 2020
Primary completion	18 April 2025
Estimated completion	18 April 2025
Sites	8 locations across Italy, France, Brazil, Argentina, Spain

Drugs / interventions tested

• niPGT-A
• Morphology criteria

Conditions studied

• Aneuploidy — all drugs for Aneuploidy →
• Chromosome Abnormality — all drugs for Chromosome Abnormality →
• Infertility — all drugs for Infertility →

Sponsor

Igenomix

Who can join

Adults 20 to 40, female only, with Aneuploidy or Chromosome Abnormality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chromosomal aneuploidies are linked with spontaneous miscarriages and abnormal offspring in human pregnancies. In addition, some types of aneuploidies are reported to prevent implantation. Thus, there is a need to identify the embryos with highest implantation potential on in vitro fertilization (IVF) programs.

Since embryo morphology and kinetics have a weak association with embryo ploidy, trophectoderm biopsy plus Next-Generation Sequencing (NGS) is becoming a very popular approach to determine the embryo chromosomal status. This technique is called Preimplantation Genetic Testing for Aneuploidy (PGT-A). Although shown to be efficient, it is invasive for the embryo, requires specific technical skills and it remains expensive. Therefore, the development of a non-invasive, rapid and cheaper method for assessing embryo ploidy status would represent a progress in the field of IVF.

The non-invasive approach has been explored by some groups that analyzed the Spent Blastocyst Medium (SBM) where the embryo was incubated up to the time of transfer or freezing. In daily routine, this media is discarded after finishing the culture of the embryo. Importantly, though, this media reportedly contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo.

On the basis of that, the hypothesis of this study is that embryo prioritization according to the analysis of the embryonic cfDNA in the SBM could improve ongoing pregnancy rate in 10 percentual points compared to standard blastocyst transfer based on morphology.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preimplantation Genetic Testing for Chromosomal Abnormalities: Aneuploidy, Mosaicism, and Structural Rearrangements.
   Viotti M. · · 2020 · cited 112× · PMID 32485954 · DOI 10.3390/genes11060602
2. A Mini-Review Regarding the Clinical Outcomes of In Vitro Fertilization (IVF) Following Pre-Implantation Genetic Testing (PGT)-Next Generation Sequencing (NGS) Approach.
   Doroftei B, Ilie OD, Anton N, Armeanu T, et al · · 2022 · cited 10× · PMID 36010262 · DOI 10.3390/diagnostics12081911