RecruitingNot ApplicableNCT07425080

HELIOS Advanced: Human Oocyte Illumination to Enhance Development

HELIOS-Advanced: A Prospective, Staged Dose-Escalation Study of Photobiomodulation to Improve Embryo Development in In Vitro Fertilization


Sponsor

Columbia University

Enrollment

270 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 48 Years

Inclusion Criteria6

  • 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 Criteria3

  • Use of donor oocytes or gestational carrier
  • Concurrent experimental laboratory inventions outside of protocol
  • Refusal of randomization or request for non-standard handling

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Interventions

OTHERPhotobiomodulation

Photobiomodulation (PBM): also known as low-level light therapy (LLLT), involves the application of low-intensity red or near-infrared (NIR) light to modulate mitochondrial activity.


Locations(1)

Columbia University Fertility Center

New York, New York, United States

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NCT07425080


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