NCT06524648 International Pilot Study for Dual Non-invasive Assesment of Embryo Development
| NCT ID | NCT06524648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Igenomix |
| Condition | Infertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-10-29 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Luis Navarro, PhD
PRINCIPAL INVESTIGATOR
Igenomix
Frequently Asked Questions
Who can join the NCT06524648 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 42 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06524648 currently recruiting?
Yes, NCT06524648 is actively recruiting participants. Contact the research team at carlos.gomez@igenomix.com for enrollment information.
Where is the NCT06524648 trial being conducted?
This trial is being conducted at Dobl, Austria, Barcelona, Spain, Madrid, Spain, Murcia, Spain and 4 additional locations.
Who is sponsoring the NCT06524648 clinical trial?
NCT06524648 is sponsored by Igenomix. The principal investigator is Luis Navarro, PhD at Igenomix. The trial plans to enroll 200 participants.