HELIOS Advanced: Human Oocyte Illumination to Enhance Development
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Columbia University
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Number of usable blastocysts
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
All embryos will be coded and tracked with blinded identifiers. Embryologists and clinicals selecting embryos for transfer will be blinded to treatment group. Selection will follow routine morphological and PGT-A criteria.
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female age between 18-48 years at the time of the IVF/ICSI cycle
- •Undergoing blastocyst culture and PGT-A
- •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
Arms & Interventions
No photobiomodulation
Photobiomodulation
Intervention: Photobiomodulation (Other)
Outcomes
Primary Outcomes
Number of usable blastocysts
Time Frame: Seven days post egg retrieval
Usable blastocysts are defined as blastocysts that can be biopsied and frozen on Day 5, 6, or 7 of development for PGT-A (pre-implantation genetic testing for aneuploidy). We will calculate the usable blastocyst rate per oocyte retrieved defined as the number of usable blastocysts divided by the number of oocytes retrieved.
Secondary Outcomes
- Maturity Rate(Up to seven days post egg retrieval)
- Fertilization Rate(Up to seven days post egg retrieval)
- tPNf(Up to seven days post egg retrieval)
- Time to 2-cell stage(Up to seven days post egg retrieval)
- Time to 3-cell stage(Up to seven days post egg retrieval)
- Time to 6-cell stage(Up to seven days post egg retrieval)
- Time to 8-cell stage(Up to seven days post egg retrieval)
- Time to morula(Up to seven days post egg retrieval)
- Time to start of blastulation(Up to seven days post egg retrieval)
- Time to blastocyst(Up to seven days post egg retrieval)
- Time to hatching blastocyst(Up to seven days post egg retrieval)
- Number of good quality blastocysts as defined by Gardner grading system(Up to seven days post egg retrieval)
- Euploidy Rate(Within 30 days post egg retrieval)
- Proportion of Embryo Selected for Transfer(Within 1 year post egg retrieval)
- Implantation Rate(Within 1 year post egg retrieval)
- Clinical pregnancy rate(Within 1 year post egg retrieval)
- Miscarriage rate(Within 1 year of egg retrieval)
- Live birth rate(Up to 2 years post egg retrieval)
- Gestational Age at Delivery(Up to 2 years post egg retrieval)
- Birthweight(Up to 2 years post egg retrieval)
Investigators
Samuel Zev Williams
Director of Columbia University Fertility Center; Wendy D. Havens Associate Professor of Women's Health; Chief of the Division of Reproductive Endocrinology and Infertility at Columbia University Irving Medical Center
Columbia University