Actively Recruiting
HELIOS-Advanced: Photobiomodulation to Improve Embryo Development in IVF Using Autologous Oocytes
Led by Columbia University · Updated on 2026-03-25
270
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve embryo development and pregnancy success in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). It focuses on how energy production in oocytes decreases with age due to mitochondrial dysfunction, which affects embryo quality. The study evaluates whether adding a gentle light therapy called photobiomodulation (PBM) during IVF can boost mitochondrial activity and enhance embryo growth, especially in women of advanced maternal age. Participants receive standard IVF or ICSI treatment with preimplantation genetic testing for aneuploidy (PGT-A). Their oocytes are randomly assigned to either receive PBM, a low-intensity red or near-infrared light therapy aimed at improving mitochondrial function, or no additional light treatment. This randomized, triple-blinded sibling-oocyte design allows direct comparison within the same participant's eggs. The treatment focuses on early embryo stages, with follow-up on blastocyst development and pregnancy outcomes. During the study, researchers will closely monitor embryo development milestones up to seven days after egg retrieval, including fertilization rates, cell division timing, blastocyst quality, and genetic normality. Pregnancy outcomes, such as implantation, clinical pregnancy rates, miscarriage, live birth, and birth statistics, will be tracked for up to two years. Participants’ embryos are assessed using genetic testing and grading systems, and results will help determine if PBM can positively influence IVF success.
CONDITIONS
Brief Title
HELIOS Advanced: Human Oocyte Illumination to Enhance Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Use of donor oocytes or gestational carrier
- Concurrent experimental laboratory inventions outside of protocol
- Refusal of randomization or request for non-standard handling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 7 days post egg retrieval
Participants undergo IVF or ICSI cycles with preimplantation genetic testing for aneuploidy (PGT-A) using their own oocytes. Resultant oocytes are randomized to receive photobiomodulation (PBM) or no PBM to evaluate effects on embryo development.
1 baseline visit for egg retrieval and daily embryo assessments for up to 7 days
Duration - Up to 2 years post egg retrieval
Participants are followed for pregnancy outcomes, including embryo transfer, clinical pregnancy, and birth outcomes.
Visits as needed for embryo transfer and pregnancy monitoring within 1 year, plus follow-up visits up to 2 years for birth outcomes
Trial Site Locations
Total: 1 location
1
Columbia University Fertility Center
New York, New York, United States, 10019
Actively Recruiting
Research Team
S
Samuel Zev Williams, MD, PhD
L
Laura C Gemmell, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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