HELIOS Advanced: Human Oocyte Illumination to Enhance Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation.
- Who it may be relevant to
- Registry conditions: IVF Outcomes. Basic parameters: 18 years — 48 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
HELIOS-Advanced: A Prospective, Staged Dose-Escalation Study of Photobiomodulation to Improve Embryo Development in In Vitro Fertilization
Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of usable blastocysts [Time frame: Seven days post egg retrieval]
Secondary outcome measures (12)
- Maturity Rate [Time frame: Up to seven days post egg retrieval]
- Fertilization Rate [Time frame: Up to seven days post egg retrieval]
- tPNf [Time frame: Up to seven days post egg retrieval]
- Time to 2-cell stage [Time frame: Up to seven days post egg retrieval]
- Time to 3-cell stage [Time frame: Up to seven days post egg retrieval]
- Time to 6-cell stage [Time frame: Up to seven days post egg retrieval]
- Time to 8-cell stage [Time frame: Up to seven days post egg retrieval]
- Time to morula [Time frame: Up to seven days post egg retrieval]
- Time to start of blastulation [Time frame: Up to seven days post egg retrieval]
- Time to blastocyst [Time frame: Up to seven days post egg retrieval]
- Time to hatching blastocyst [Time frame: Up to seven days post egg retrieval]
- Number of good quality blastocysts as defined by Gardner grading system [Time frame: Up to seven days post egg retrieval]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University Fertility Center — New York
Identifiers
NCT: NCT07425080 · ACYY1279