NCT06524648

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

A Prospective, Multicenter, Observational Pilot Study to Evaluate the Combination of niPGT-A and Morphokinetics for the Non-invasive Assessment of Embryo Development

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Igenomix · Industry
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Embryo selection represents one of the major challenges for achieving success in in vitro fertilization (IVF) cycles. Traditionally, embryo evaluation has been based on morphological quality and chromosomal status as diagnosed by a genetic testing. However, recently new non-invasive techniques that do not require additional manipulation of the embryo have been developed and have shown promising results. One such technique is the time-lapse (TL) system imaging, which considers the embryo's development in relation to its rate of division and evolution (morphokinetics). Several algorithms have been developed to aid in the selection of embryos with the highest potential for implantation by collecting data on morphokinetic events during in vitro preimplantation development. Another non-invasive method is the analysis of the cell-free desoxyribonucleic acid (cfDNA) in the culture medium, considered as a non-invasive preimplantation genetic testing for aneuploidies (niPGT-A). Despite both techniques have shown promising results, each one has its limitations, and further research is necessary to identify synergies between them with the aim of finding a more powerful approach for embryo viability evaluation. The combination of TL and niPGT-A might have the potential to improve the embryo evaluation and thus to improve the reproductive outcome rates in IVF treatments. Therefore, the aim of the present pilot study is to identify morphokinetic parameters during embryo development in a time-lapse system which may correlate with niPGT-A results. Once the study is approved by the competent Research Ethics Committee of each center, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent. To comply with the study design and the proposed hypothesis, an estimated total number of 200 patients will be recruited. This is a multicenter, international, competitive, observational, prospective cohort study in which infertile women scheduled for an IVF/ICSI treatment with medical recommendation of niPGT-A will have their embryos cultured in a time-lapse system instead of in a standard incubator. On day 6/7 of embryo development, the embryo's culture medium will be collected and analyzed by niPGT-A. A subsequent embryo transfer will be performed following the niPGT-A report recommendation and participants will be followed up as routine by their gynecologist. If a pregnancy is achieved, participants will be followed up until the 12th gestational week and, if possible, until the delivery. If pregnancy is not achieved, patients can perform as many SET/COS as they need during the study recruitment period. Data exported from the medical records and source documents will be duly codified to protect the clinical and personal information of patients in accordance with the current legislation on data protection. This information will be exported to an internal database. An interim data analysis will be carried out once the 50% of the niPGT-A cycles (100 cycles) is reached. It will help us to assess the enrollment rate, protocol compliance and an early evaluation of the study objectives. Patient´s participation will comprise an estimated total time of up to 11 months: 1 month for the COS cycle + 1 month for the ET cycle + ≤ 9 months for the follow-up period (≤12th gestational week and ≤ 40th gestational week, when applicable).

Conditions

• Infertility

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-02-01
• Completion: 2027-01-01
• First posted: 2024-07-29
• Last updated: 2025-08-01

Locations

8 sites across 3 countries: Austria, Spain, United Arab Emirates