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International Pilot Study for Dual Non-invasive Assesment of Embryo Development

NCT06524648 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-08-01

No results posted yet for this study

Summary

Choosing the best embryo is one of the major challenges for achieving success in in vitro fertilization (IVF). Traditionally, embryo evaluation has been based on morphological quality (how the embryo looks like) and chromosomal status as diagnosed by a genetic testing. However, recently new techniques that do not require manipulation of the embryo have been developed and have shown promising results.

The goal of this observational study is, by combining two non-invasive techniques, to find out some parameters during embryo development which may be related with the embryo's chromosomic status. For that, infertile women planning to undergo an IVF/ICSI treatment with a recommended niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) will be invited to join the study. The main question it aims to answer is:

* Can morphokinetics parameters correlate with embryo chromosomal status?

Participants will follow their previously programmed IVF/ICSI treatment and no additional visits/interventions will be required by their participation in the study. The obtained embryos will be cultured in a time-lapse system instead of in a conventional incubator, and niPGT-A will be performed. Following the standard practice, a deferred single embryo transfer (SET) will be performed according to the niPGT-A results. After the transfer, patients will be followed-up as usual.

Conditions

Interventions

DIAGNOSTIC_TEST

niPGT-A

Embryos will be cultured, from oocyte fertilization up to day 6/7 of development, in a time lapse system following the standard practice. On day 6/7, embryos will be vitrified and the embryos's media will be collected for niPGT-A analysis. Patients will undergo a single embryo transfer (SET) following the niPGT-A report indications. In the event of 1 or more embryos with the same niPGT-A score, the embryo for transfer will be determined by the site standard practice (morphology or time-lapse score). Patients who do not achieve a pregnancy after a niPGT-A guided SET can undergo as many niPGT-A guided SET or COS+niPGT-A cycles as they need to get pregnant, while the study recruitment phase is active.

Sponsors & Collaborators

  • Igenomix

    lead INDUSTRY

Principal Investigators

  • Luis Navarro, PhD · Igenomix

  • Carmen Rubio, PhD · Igenomix

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2026-02-28
Completion
2027-01-31

Countries

  • Austria
  • Spain
  • United Arab Emirates

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524648 on ClinicalTrials.gov