Non-invasive testing for embryo chromosomal status in IVF
Randomized Controlled Clinical Study to Assess the Benefit of Non-invasive PGT-A, by the Analysis of Spent Blastocyst Media, as a Tool for Embryo Prioritization in Infertile Patients Undergoing Assisted Reproduction.
This study is testing a new way to check if embryos are healthy during IVF by analyzing the fluid they grow in, instead of taking a sample from the embryo itself, to help patients have safer and more affordable options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1108 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Igenomix Industry-sponsored |
| Locations | 11 sites (Boston, Massachusetts and 10 other locations) |
| Trial ID | NCT04000152 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a non-invasive method for assessing embryo chromosomal status using spent blastocyst medium (SBM) during in vitro fertilization (IVF). By analyzing cell-free DNA released into the culture medium, the study seeks to provide an alternative to the invasive trophectoderm biopsy currently used in Preimplantation Genetic Testing for Aneuploidy (PGT-A). The approach could reduce costs and risks associated with embryo manipulation while maintaining high accuracy in identifying embryos with the highest implantation potential. The study will involve IVF patients who are undergoing deferred blastocyst transfer and will follow specific laboratory protocols for embryo culture and vitrification.
Who should consider this trial
Good fit: Ideal candidates for this study are IVF patients aged 20-40 who are not undergoing PGT-A and are willing to participate in a non-invasive testing approach.
Not a fit: Patients with known abnormal karyotypes or those requiring assisted hatching before sample collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve embryo selection processes, leading to higher implantation rates and reduced miscarriage risks for IVF patients.
How similar studies have performed: Previous pilot studies have shown promising concordance rates between non-invasive testing and traditional biopsy methods, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. * IVF patients intending to undergo deferred day 6/7 blastocyst SET for any medical indication. * All the oocytes/embryos from the cycle should follow the laboratory protocol described in the study (embryo culture and vitrification on day 6/7). * ICSI, IVF or ICSI/IVF performed in fresh own oocytes from couples not undergoing PGT-A. Note: Donor sperm is allowed. * Female age: 20-40 years, both included. Exclusion Criteria: * Assisted hatching and artificial collapse before collecting SBM samples. Note: Both procedures are allowed only after collecting the culture media sample. * A known abnormal karyotype if the couple provides it at consultation. If not, karyotype is not compulsory. * Couples planning to undergo PGT-M or PGT-SR cases will be excluded. * Surrogate pregnancy (in those countries where it is allowed). * ERA test and embryo transfer according to ERA result. * Time-lapse culture systems are not allowed after day 4 of culture. * Presence of pathologies or malformations that affect the uterine cavity such as polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx during the patient's participation in the study. Patients suffering these pathologies before or after their inclusion in the study can participate if the pathology is corrected before performing any study procedure. * 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
Boston, Massachusetts and 10 other locations
- Boston IVF Fertility Clinic — Boston, Massachusetts, United States (Recruiting)
- Crecer: Centro de Reproducción y Genética Humana — Mar Del Plata, Buenos Aires, Argentina (Recruiting)
- Saresa - Reproducción Humana Asistida — Salta, Argentina (Recruiting)
- Nilo Frantz - Centro de Reprodução Humana — Boa Vista, Porto Alegre, Brazil (Recruiting)
- Vida - Centro de Fertilidade — Rio De Janeiro, Brazil (Recruiting)
- Hôpital Foch — Suresnes, France (Recruiting)
- Società Italiana Studi di Medicina della Riproduzione (S.I.S.M.e.R.) — Bologna, Italy (Recruiting)
- Centro Procreazione Assistita DEMETRA — Firenze, Italy (Recruiting)
- Promea S.p.A — Torino, Italy (Recruiting)
- Eugin Madrid — Madrid, Spain (Not_yet_recruiting)
- Hospital Ruber Internacional — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Carmen Rubio, PhD — Igenomix S.L.
- Study coordinator: Carlos Gómez, BSc MSc
- Email: carlos.gomez@igenomix.com
- Phone: +34 963905310
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.