Non-invasive assessment of embryo development for IVF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to improve embryo selection in in vitro fertilization (IVF) by combining two non-invasive techniques: time-lapse imaging and non-invasive preimplantation genetic testing for aneuploidies (niPGT-A). The study will evaluate morphokinetic parameters during embryo development to determine their correlation with chromosomal status. Infertile women undergoing IVF/ICSI treatment will be invited to participate, following their planned procedures without additional interventions. The goal is to enhance embryo viability evaluation and improve reproductive outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kinderwunsch Institut Schenk
  Dobl, Austria Recruiting
• Fertty
  Barcelona, Barcelona, Spain Recruiting
• Hospital Ruber Internacional
  Madrid, Madrid, Spain Recruiting
• Next Fertility Murcia
  Murcia, Murcia, Spain Recruiting
• Next Fertility Sevilla
  Seville, Sevilla, Spain Recruiting
• Next Fertility Valencia
  Valencia, Valencia, Spain Recruiting

Study contacts

• Principal investigator: Luis Navarro, PhD — Igenomix
• Study coordinator: Carlos Gomez, BSc MSc
• Email: carlos.gomez@igenomix.com
• Phone: +34963905310

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.