Non-invasive embryo selection using metabolomics in IVF
Non-Selection Trial Comparing Metabolomics to Morphology Embryo Selection
This study is testing if analyzing the fluids from developing embryos can help choose the best embryos for implantation during IVF to improve success rates.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 410 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Overture Life Industry-sponsored |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04878991 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the potential of metabolomic screening for embryo selection in in vitro fertilization (IVF). Investigators will collect spent culture media from embryos on day 5 of culture, which will be analyzed for specific analytes secreted by the developing embryos. The study will involve ovarian stimulation, egg retrieval, and fertilization through intracytoplasmic sperm injection (ICSI), followed by single embryo transfer based on morphology. The outcomes of the embryo transfer will be compared to metabolomic analysis results to assess the effectiveness of this new selection method.
Who should consider this trial
Good fit: Ideal candidates include women of any age undergoing IVF, particularly those with embryos available for transfer.
Not a fit: Patients requiring preimplantation genetic testing or those with low ovarian reserve may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve embryo selection and increase the chances of successful implantation and pregnancy for patients undergoing IVF.
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, including egg donors. 50% will be \<35 and the rest 35 and older. * 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
New York, New York and 1 other locations
- New Hope Fertility Center — New York, New York, United States (Recruiting)
- Clinical Juana Crespo — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Jose Horcajadas, PhD — Overture Life
- Study coordinator: Beatriz Maroto
- Email: beatriz@overture.life
- Phone: 620521878
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.