NCT07425080

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

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.

Detailed description

Embryo development is highly energy-dependent, and impaired mitochondrial function is a well-established hallmark of reproductive aging. As women age, reactive oxygen species (ROS) accumulate and cause mitochondrial DNA (mtDNA) damage, leading to reduced oxidative phosphorylation, ATP (Adenosine 5'-triphosphate) depletion, and developmental arrest of embryos. Enhancing mitochondrial function represents a promising strategy to improve embryo quality, particularly in women of advanced maternal age. 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. NIR light specifically activates cytochrome c oxidase, leading to increased ATP production, reduced oxidative stress, and improved cellular resilience. Numerous preclinical studies, including isolated mitochondria, cell cultures, and in vivo animal models, have confirmed the safety and efficacy of NIR light in restoring mitochondrial function without inducing DNA damage or chromosomal abnormalities. The investigators previously conducted IRB-approved laboratory studies using mouse and donated human embryos, demonstrating that brief exposure to PBM improved blastocyst formation without adversely affecting chromosomal status. The current study builds upon this foundational work to evaluate the clinical impact of PBM at the oocyte stage. In a randomized, blinded, sibling-oocyte design, the investigators will test whether PBM improves fertilization rates, blastocyst formation, embryo quality, and pregnancy outcomes in participants undergoing IVF or ICSI (Intracytoplasmic sperm injection) with PGT-A (preimplantation genetic testing for aneuploidy) using their autologous oocytes.

Conditions

• IVF Outcomes

Interventions

Type	Name	Description
OTHER	Photobiomodulation	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.

Timeline

• Start date: 2026-03-24
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2026-02-20
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States