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HELIOS: Human Embryo Illumination to Enhance Development

NCT ID: NCT07311928

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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Embryo development is highly energy-dependent, and impaired mitochondrial function is a well-established hallmark of reproductive aging. As women age, reactive oxygen species (ROS) accumulate and cause mitochondrial DNA (mtDNA) damage, leading to reduced oxidative phosphorylation, ATP (Adenosine 5'-triphosphate) depletion, and developmental arrest of embryos. Enhancing mitochondrial function represents a promising strategy to improve embryo quality, particularly in women of advanced maternal age.

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. NIR light specifically activates cytochrome c oxidase, leading to increased ATP production, reduced oxidative stress, and improved cellular resilience. Numerous preclinical studies, including isolated mitochondria, cell cultures, and in vivo animal models, have confirmed the safety and efficacy of NIR light in restoring mitochondrial function without inducing DNA damage or chromosomal abnormalities.

The investigators previously conducted IRB-approved laboratory studies using mouse and donated human embryos, demonstrating that brief exposure to PBM improved blastocyst formation without adversely affecting chromosomal status.

The current study builds upon this foundational work to evaluate the clinical impact of PBM during embryo culture in IVF. In a randomized, blinded, sibling-embryo design, the investigators will test whether PBM improves blastocyst formation, embryo quality, and pregnancy outcomes in participants undergoing IVF or ICSI (Intracytoplasmic sperm injection) with PGT-A (preimplantation genetic testing for aneuploidy) using their autologous oocytes.

Conditions

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IVF Outcomes

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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No photobiomodulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Photobiomodulation

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type 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.

Interventions

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Photobiomodulation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Use of donor eggs
* Known uterine or genetic anomalies
* Refusal of randomization or request for non-standard handling
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Samuel Zev Williams

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel Zev Williams, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Fertility Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Samuel Zev Williams, MD, PhD

Role: CONTACT

Phone: 646-756-8282

Email: [email protected]

Laura C Gemmell, MD, MSc

Role: CONTACT

Phone: 617-835-8241

Email: [email protected]

Facility Contacts

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Laura Gemmell, MD

Role: primary

Other Identifiers

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AAAV9656

Identifier Type: -

Identifier Source: org_study_id