International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Recruiting now
Conditions studied: Infertility
In brief
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.
Key facts
- Study ID
- NCT06524648
- Run by
- Igenomix
- People needed
- 200
- Starts
- 2024-10-29
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-08-01
Who can join
Age: 20 and older, up to 42. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Kinderwunsch Institut Schenk — Dobl, Austria (enrolling)
- Fertty — Barcelona, Barcelona, Spain (enrolling)
- Hospital Ruber Internacional — Madrid, Madrid, Spain (enrolling)
- Next Fertility Murcia — Murcia, Murcia, Spain (enrolling)
- Next Fertility Sevilla — Seville, Sevilla, Spain (enrolling)
- Next Fertility Valencia — Valencia, Valencia, Spain (enrolling)
- Vida Recoletas Sevilla — Seville, Spain (enrolling)
- Orchid IVF Clinic — Dubai, United Arab Emirates (enrolling)
Full record on ClinicalTrials.gov
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