HELIOS: Human Embryo Illumination to Enhance Development

NCT07311928 | Active Not Recruiting DMC

• 1 other identifier: AAAV9656
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Embryos need a lot of energy to grow, but as women get older, the "power plants" of the cells (called mitochondria) don't work as well. This makes it harder for 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 chances.

Conditions

IVF Outcomes

Keywords

infertility; embryo arrest; recurrent implantation failure; recurrent pregnancy loss; fertility; sperm dna fragmentation

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 testing (preimplantation genetic testing for aneuploidy).

  Seven days after egg retrieval

Secondary Outcomes (15)

• 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

Study Arms (2)

No photobiomodulation

NO INTERVENTION

Participants will receive the same treatment (IVF/ICSI cycle with PGT-A). Each participant's resultant embryos will be randomized to not receive PBM.

Photobiomodulation

EXPERIMENTAL

Participants will receive the same treatment (IVF/ICSI cycle with PGT-A). Each participant's resultant embryos 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: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female age between 18-48 years at time of IVF/ICSI cycle
• Undergoing blastocyst culture and PGT-A
• Using own oocytes
• Have at least two fertilized eggs available for randomization
• Consenting to embryo-level randomization
• Plan to transfer euploid embryo within 6 months

You may not qualify if:

• Use of donor eggs
• Known uterine or genetic anomalies
• 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

Location

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

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 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-embryo-randomized, double-blind controlled trial. All participants will receive the same treatment (IVF/ICSI cycle with PGT-A). Each participant's resultant embryos will be randomized into two groups (one group receiving PBM, the other not).

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: December 3, 2025
• 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)