NCT07425080 HELIOS Advanced: Human Oocyte Illumination to Enhance Development
| NCT ID | NCT07425080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | IVF Outcomes |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2027-06-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Oocytes need a lot of energy to complete meiosis and fertilize successfully. As women get older, the "power plants" of the cells (called mitochondria) don't work as well. This makes it harder for eggs and embryos to develop normally. One possible way to help is with a gentle light treatment called photobiomodulation (PBM). This uses a special type of red light that boosts energy production in cells and helps them stay healthy. This study will test whether adding this light treatment during in vitro fertilization (IVF) can improve embryo growth and pregnancy outcomes.
Eligibility Criteria
Inclusion Criteria: * Female age between 18-48 years at the time of the IVF/ICSI cycle * Undergoing blastocyst culture * Using own oocytes * Has at least two oocytes available for randomization * Consenting to oocyte level randomization * Plan to transfer euploid embryo within 6 months Exclusion Criteria: * Use of donor oocytes or gestational carrier * Concurrent experimental laboratory inventions outside of protocol * Refusal of randomization or request for non-standard handling