Red/near-infrared light to boost egg energy and improve IVF outcomes
HELIOS-Advanced: A Prospective, Staged Dose-Escalation Study of Photobiomodulation to Improve Embryo Development in In Vitro Fertilization
This study will test whether briefly shining red/near-infrared light on eggs during IVF helps them make healthier embryos and raises pregnancy chances for people using their own oocytes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07425080 on ClinicalTrials.gov |
What this trial studies
Photobiomodulation (PBM) uses low-intensity red or near-infrared light to stimulate mitochondria and increase cellular ATP production. In a randomized, blinded, sibling-oocyte design, individual oocytes from the same patient are randomized to brief PBM exposure or standard handling before fertilization, with embryos cultured to the blastocyst stage and planned euploid transfer within six months. Primary outcomes include blastocyst formation and embryo developmental metrics, with secondary outcomes tracking euploid transfer rates and pregnancy outcomes. The trial is conducted at Columbia University Fertility Center and builds on prior laboratory and animal work showing improved blastocyst formation without chromosomal damage.
Who should consider this trial
Good fit: Ideal candidates are people aged 18–48 undergoing IVF/ICSI with their own oocytes who have at least two oocytes available for randomization and plan to transfer a euploid embryo within six months.
Not a fit: Persons using donor eggs or a gestational carrier, those with fewer than two available oocytes, or those undergoing other experimental lab procedures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, PBM could increase embryo quality and improve pregnancy rates for patients, particularly those of advanced reproductive age.
How similar studies have performed: Preclinical and laboratory studies in animals and donated human embryos by the investigators showed brief PBM improved blastocyst formation without causing chromosomal abnormalities, but this is the first randomized clinical test at the oocyte stage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Columbia University Fertility Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Zev Williams, MD/PhD — Columbia University
- Study coordinator: Samuel Zev Williams, MD, PhD
- Email: zw2421@cumc.columbia.edu
- Phone: 646-756-8282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.