Non-invasive embryo selection using metabolomics in IVF
Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media
Overture Life · NCT04976920
This study is testing if analyzing the fluid from growing embryos can help choose the best ones for IVF, so patients can have a better chance of getting pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 205 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Overture Life (industry) |
| Locations | 2 sites (Buenos Aires and 1 other locations) |
| Trial ID | NCT04976920 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze embryo culture media from patients undergoing in vitro fertilization (IVF) to assess the potential of metabolomics as a non-invasive method for embryo selection. Patients will undergo standard IVF procedures, including ovarian stimulation and egg retrieval, with spent culture media collected on day 5 or 6 for metabolomic analysis. The results will be compared to traditional embryo selection methods to evaluate the accuracy of metabolomics in predicting implantation success. The study will monitor pregnancy outcomes following embryo transfer to establish the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates include women of any age undergoing IVF, particularly those without low ovarian reserve and who do not require preimplantation genetic testing.
Not a fit: Patients who require preimplantation genetic testing or have low ovarian reserve may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could enhance embryo selection processes, potentially leading to higher implantation rates and improved IVF outcomes.
How similar studies have performed: While the use of metabolomics in embryo selection is a novel approach, similar studies have shown promising results in improving embryo selection methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women of any age, 25% of patients \<35 years, 25% of patients 35-37, 25% of patients 38-40, and 25% of patients \>40 years. * Signed Subject Consent Form. No inferior limit on number of eggs Exclusion Criteria: At the time of initial visit: * Require or request PGT of any kind * Low ovarian reserve defined as follicle stimulating hormone (FSH) \>10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) \<15 pmol/L (or \<2 ng/ml) within prior 12 months of cycle start At the time of embryo selection: -Patients without at least one embryo to transfer.
Where this trial is running
Buenos Aires and 1 other locations
- Grupo Procrearte — Buenos Aires, Argentina (RECRUITING)
- Clinical Juana Crespo — Valencia, Spain (RECRUITING)
Study contacts
- Principal investigator: Jose Horcajadas, PhD — Overture Life
- Study coordinator: Alexander Nadal
- Email: alex@overture.life
- Phone: 323-420-6343
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, IVF, genetic screening, preimplantation genetic testing