Recruiting

niPGT-A

Sponsor:

Igenomix

Code:

NCT04000152

Conditions

Aneuploidy

Chromosome Abnormality

Infertility

Eligibility Criteria

Sex: Female

Age: 20 - 40

Healthy Volunteers: Not accepted

Interventions

niPGT-A

Morphology criteria

Study Details

Brief summary:

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.

Conditions

Aneuploidy

Chromosome Abnormality

Infertility

Study ID

NCT04000152

Start date

Jun 29, 2020

Status verified date

Dec, 2022

Completion date

Jun, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication.
  • All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7).
  • ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed.
  • Female age: 20-40 years, both included.

Exclusion Criteria:

  • Assisted hatching and artificial collapse before collecting SBM samples. Note: Both procedures are allowed only after collecting the culture media sample.
  • A known abnormal karyotype if the couple provides it at consultation. If not, karyotype is not compulsory.
  • Couples planning to undergo PGT-M or PGT-SR cases will be excluded.
  • Surrogate pregnancy (in those countries where it is allowed).
  • ERA test and embryo transfer according to ERA result.
  • Time-lapse culture systems are not allowed after day 4 of culture.
  • 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 can 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.

Study Design

Enrollment

1108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Control group (group 1)

Deferred single day 6/7 blastocyst transfer with blastocyst selection according to morphology.

experimental: Intervention group (group 2)

Deferred single day 6/7 blastocyst transfer with blastocyst selection according to the analysis of the spent culture media (niPGT-A).

Interventions

niPGT-A

Two scenarios should be considered according to the results in the SBM analysis:

1. The couple decides to transfer the blastocyst selected according to the SBM result (blastocyst prioritization system).
2. The couple decides to biopsy the blastocysts (if SBM results show low euploidy score). This PGT-A analysis will be offered for free but the outcome of these transfers will be excluded for the analysis per completed protocol. However, all transfers will be included in the intention-to-treat analysis.

In the exceptional case of getting a non-informative result for all the SBM analysed, the niPGT-A could be performed again on new SBM samples collected after an additional culture of the embryos for, at least, 8 hours.

Morphology criteria

Embryos for transfer will be selected by the only applicable technique, the assessment of morphology according to Gardner´s criteria, which is the most standardized method.

Primary outcome measure

  • Non-invasive analysis of the chromosomal status of the embryo [ Time Frame: 7 days ]
  • Ongoing pregnancy rate [ Time Frame: Over 12 weeks ]

Central Contacts and Locations

Central contacts

Carlos Gómez, BSc MSc

+34 963905310carlos.gomez@igenomix.com

Carmen Rubio, PhD

+34 963905310carmen.rubio@igenomix.com

Locations

Boston IVF Fertility Clinic

Recruiting

Boston, Massachusetts, United States, 02109

Contacts

Denny Sakkas, PhD

888-300-2438DSakkas@BOSTONIVF.com

Alison J Meyers, BS

AMeyers@bostonivf.com

Principal Investigator:

Denny Sakkas, PhD

More Information

Sponsor

Igenomix

Last update posted

Dec 15, 2022

Last verified

Dec, 2022

Keywords

  • Blastocyst
  • Non-invasive
  • PGT-A
  • Aneuploidy
  • Spent culture medium
  • Trophectoderm biopsy
  • Sustained implantation
  • Miscarriage
  • Livebirth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Igenomix on 2022-12-15.