Analyzing genetic material from embryo culture media to improve IVF outcomes
Observational Study to Investigate the Correlation of the Genetic Constitution of the Spent Blastocyst Media (SBM) with the Inner Cell Mass (ICM) and Multifocal Trophectoderm (TE) Biopsies
Igenomix · NCT06780605
This study is testing a new way to check the genetics of embryos in IVF by looking at the fluid they sit in, to see if it can help choose the best embryos without needing to take samples from them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Igenomix (industry) |
| Locations | 2 sites (Nicosia and 1 other locations) |
| Trial ID | NCT06780605 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance non-invasive Preimplantation Genetic Testing for Aneuploidies (niPGT-A) by analyzing the genetic material released by embryos into the culture medium, known as Spent Blastocyst Media (SBM). Approximately 200 blastocysts donated by patients undergoing assisted reproduction treatments will be studied, correlating the genetic content in SBM with biopsies taken from the trophectoderm and inner cell mass of the embryos. The goal is to better understand the genetic constitution of blastocysts and improve embryo selection methods without the need for invasive biopsies.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing IVF/ICSI cycles with aneuploid or euploid blastocysts willing to donate surplus embryos for research.
Not a fit: Patients with blastocysts that did not survive vitrification or have poor quality will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective embryo selection in IVF, reducing the need for invasive procedures.
How similar studies have performed: Previous pilot studies have shown promising results with similar non-invasive approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study informed consent form, approved by the Ethics Committee, signed. * Any patient with aneuploid or euploid blastocysts from PGT-A cycles donated for research. * Patients undergoing regular IVF/ICSI cycles aiming to donate surplus embryos for research. * Embryos from own or donated oocytes can be included. * Embryos fertilized with donated sperm can be included. * Only blastocysts with proper re-expansion and good quality after thawing will be included. Exclusion Criteria: * Blastocysts that had not survived to vitrification, that had not re-expanded properly or having poor ICM or TE quality. Note: No exclusion criteria specific to the patients' background will be considered.
Where this trial is running
Nicosia and 1 other locations
- British Cyprus IVF Hospital — Nicosia, Cyprus (RECRUITING)
- Ventus IVF Center — Nicosia, Cyprus (RECRUITING)
Study contacts
- Principal investigator: Pere Mir Pardo, PhD — Igenomix
- Study coordinator: Carlos A Gomez De La Cruz, 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.
Conditions: Infertility, PGT-A, Trophectoderm, Inner cell mass, Blastocyst, In vitro fertilization, niPGT-A, Embryo development