Using AI to improve oocyte sorting in IVF for better pregnancy outcomes
NiOS (Non-Invasive Oocyte Sorting) Study
This study is testing whether an AI tool can help sort eggs better during IVF to see if it leads to more successful pregnancies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Ovation Fertility Academic / other |
| Locations | 3 sites (Las Vegas, Nevada and 2 other locations) |
| Trial ID | NCT06521372 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the use of an artificial intelligence image analysis tool, Magenta™, can enhance the sorting of oocytes for group culture in IVF, potentially increasing the yield of usable blastocysts and improving pregnancy rates. Magenta™ analyzes images of mature oocytes to predict their likelihood of successful fertilization and development into embryos. The study will assess the outcomes of IVF cycles utilizing this AI tool compared to traditional methods, focusing on the effectiveness of group culture versus single culture of oocytes.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing IVF with fresh MII oocytes and full cycle information available.
Not a fit: Patients with severe male factor infertility or those using low-quality images for analysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher pregnancy rates and better outcomes for patients undergoing IVF.
How similar studies have performed: While the use of AI in reproductive medicine is emerging, this specific approach to oocyte sorting is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fresh MII oocytes * ICSI cycles with patient's or donor's sperm * Patient's or donor's oocytes * Full IVF cycle information available (including total number of oocytes retrieved, total MII oocytes, fertilization, embryo and blastocyst development, as well as ploidy status or implantation results, and 6-7 week ultrasound, if applicable) * Good quality images of MII oocytes taken with a specified camera (Basler) and Future Fertility Software * Single embryo transfers (SETs) at blastocyst stage. * Blastocyst freeze-all cycles Exclusion Criteria: * Severe male factor infertility (\<1 million motile), including surgically retrieved sperm. * ICSI cycles inseminating in vitro matured (IVM) oocytes * Rescue ICSI oocytes (oocytes failed standard IVF and are re-inseminated by ICSI) * Low quality images - Poor quality images on day of upload or before unblinding * Lack of correlating reproductive outcomes (full IVF lab results not available). * Autologous or donor frozen/warmed oocytes * Day 3 embryo transfers or cleavage stage embryo freezing * Patients with less than 6 mature oocytes
Where this trial is running
Las Vegas, Nevada and 2 other locations
- Ovation Fertility Las Vegas — Las Vegas, Nevada, United States (Recruiting)
- Ovation Fertility Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Ovation Fertility - Nashville — Nashville, Tennessee, United States (Recruiting)
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.