Non-invasive assessment of embryo development for IVF
A Prospective, Multicenter, Observational Pilot Study to Evaluate the Combination of niPGT-A and Morphokinetics for the Non-invasive Assessment of Embryo Development
This study is testing if using time-lapse imaging and genetic testing can help choose the best embryos for women undergoing IVF to improve their chances of pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 42 Years |
| Sex | Female |
| Sponsor | Igenomix Industry-sponsored |
| Locations | 8 sites (Dobl and 7 other locations) |
| Trial ID | NCT06524648 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 42 who are planning to undergo IVF or ICSI with niPGT-A.
Not a fit: Patients with known abnormal karyotypes or certain uterine pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better embryo selection methods, increasing the chances of successful pregnancies for patients undergoing IVF.
How similar studies have performed: While both techniques have shown promise individually, this combined approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dobl and 7 other locations
- 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)
- Vida Recoletas Sevilla — Seville, Spain (Recruiting)
- Orchid IVF Clinic — Dubai, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Luis Navarro, PhD — Igenomix
- Study coordinator: Carlos Gomez, BSc MSc
- Email: carlos.gomez@igenomix.com
- Phone: +34963905310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.