HELIOS Advanced: Human Oocyte Illumination to Enhance Development

NCT07425080 | Recruiting DMC

• 1 other identifier: ACYY1279
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF Outcomes

Keywords

Infertility; Embryo arrest; Fertility

Outcome Measures

Primary Outcomes (1)

• Number of usable blastocysts

  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). The study will calculate the usable blastocyst rate per oocyte retrieved defined as the number of usable blastocysts divided by the number of oocytes retrieved.

  Seven days post egg retrieval

Secondary Outcomes (20)

• 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

Study Arms (2)

No photobiomodulation

NO INTERVENTION

Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant oocytes will be randomized to not receive PBM.

Photobiomodulation

EXPERIMENTAL

Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant oocytes will be randomized to receive PBM.

Other: Photobiomodulation

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.

Photobiomodulation

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• Use of donor oocytes or gestational carrier
• Concurrent experimental laboratory inventions outside of protocol
• Refusal of randomization or request for non-standard handling

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Fertility Center

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Samuel Zev Williams, MD/PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Zev Williams, MD, PhD

CONTACT

646-756-8282; zw2421@cumc.columbia.edu

Laura C Gemmell, MD, MSc

CONTACT

646-756-8282; lg3094@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Prospective, sibling-oocyte randomized, double-blind controlled trial. All participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Each participant's resultant oocytes will be randomized into two groups (one group receiving PBM, the other not). The study employs a pre-specified, staged dose-escalation design, beginning with the lowest biologically plausible exposure and escalating conservatively only if predefined criteria for biological activity are not met and no safety concerns are observed. This approach prioritizes risk minimization and ethical stewardship while allowing systematic evaluation of PBM efficacy.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)