RecruitingNCT06524648

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

Sponsor

Igenomix

Enrollment

200 participants

Start Date

Oct 29, 2024

Study Type

OBSERVATIONAL

Conditions

Infertility

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 42 Years

Inclusion Criteria5

Study ICF signature.
Female age between 20 and 42 years (bot included).
IVF, ICSI or IVF/ICSI performed in fresh own or donated oocytes. Note: donor sperm is allowed.
niPGT-A cases with a deferred SET (of a day 6/7 vitrified blastocyst) for any medical indication.
Embryos cultured individually in a TL system from day 0/1 to day 6/7.

Exclusion Criteria6

Embryos with abnormal fertilization (different from 2PN). (Note: In case of no 2PN embryos, patients may repeat the COS cycle).
Female/couple with PGT-M and/or PGT-SR indication.
Assisted hatching and/or artificial collapse before media collection.
Known abnormal karyotype.
Pathologies or malformations affecting the uterine cavity (polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx) during the patient's participation. (Note: patients are allowed to participate if the pathology is previously operated at least 3 months before patient enrollment).
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.

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Interventions

DIAGNOSTIC_TESTniPGT-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.