HELIOS Advanced: Human Oocyte Illumination to Enhance Development

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07425080
Status
Recruiting

Conditions

  • IVF Outcomes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 48 Years
Healthy Volunteers
Accepted

Interventions

  • Photobiomodulation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: No photobiomodulation
    Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant oocytes will be randomized to not receive PBM.
  • Experimental: Photobiomodulation
    Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant oocytes will be randomized to receive PBM.

Primary Outcome Measure

Number of usable blastocysts [ Time Frame: Seven days post egg retrieval ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Fertility CenterNew YorkNew York10019
Laura C Gemmell, MD, MSc
646-756-8282
Stephanie Morgan, MS
646-756-8282
Samuel Z Gemmell, MD, PhD (PRINCIPAL_INVESTIGATOR)

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