200 Participants Needed

Photobiomodulation for In Vitro Fertilization

(HELIOS Trial)

SZ
LC
Overseen ByLaura C Gemmell, MD, MSc
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a gentle red light treatment called photobiomodulation (PBM) can improve embryo growth during in vitro fertilization (IVF). The goal is to boost energy production in cells, as energy production often declines with age, complicating embryo development. Participants will either receive this light treatment or not, to determine if it improves pregnancy chances. Women undergoing IVF with their own eggs and having at least two fertilized eggs are ideal candidates. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance IVF success rates.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that photobiomodulation is safe for in vitro fertilization?

Research has shown that photobiomodulation, a gentle red light treatment, is generally well-tolerated. Studies have found that this therapy can increase energy production in cells without causing harm. For instance, one study on complex female infertility reported no negative effects from this treatment. Another study demonstrated that laser light, a component of photobiomodulation, improved cell function by enhancing mitochondrial performance, which acts as the cell's power plant.

Although the current trial does not specify its phase, the absence of reported side effects in previous studies suggests that photobiomodulation is safe for humans. Participants in this trial can therefore expect a similar level of safety.12345

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation for in vitro fertilization (IVF) because it offers a non-invasive, light-based approach that could enhance fertility outcomes. Unlike traditional treatments, which typically involve hormonal medications to stimulate egg production, photobiomodulation uses specific wavelengths of light to potentially improve cellular function and embryo quality. This method focuses on enhancing the body's own biological processes, which might reduce the need for extensive medication and its associated side effects. The innovative use of light therapy in this context represents a fresh avenue for improving IVF success rates.

What evidence suggests that photobiomodulation is effective for improving embryo growth and pregnancy chances in IVF?

This trial will compare the effects of photobiomodulation (PBM), a gentle red light therapy, with no photobiomodulation in the context of in vitro fertilization (IVF). Research has shown that PBM can increase energy production in cells, potentially aiding embryo development during IVF. In one study, women who received this light therapy had higher pregnancy rates than those who did not. Specifically, 46.7% of women in the PBM group experienced biochemical pregnancies, compared to lower rates in the control group. Another study found that a combination of red and near-infrared light improved fertility and reproductive health in women. PBM is a natural and non-invasive method with no reported side effects, making it a promising option for improving IVF outcomes.678910

Who Is on the Research Team?

SZ

Samuel Zev Williams, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for women aged 18-48 undergoing IVF with their own eggs and planning to use blastocyst culture and preimplantation genetic testing (PGT-A). They must have at least two fertilized eggs for the study and agree to potentially transfer a genetically normal embryo within six months.

Inclusion Criteria

Plan to transfer euploid embryo within 6 months
I am a woman aged 18-48 planning to undergo IVF/ICSI.
I am undergoing embryo screening and genetic testing.
See 3 more

Exclusion Criteria

Use of donor eggs
I have a known uterine or genetic condition.
I do not agree to be randomly assigned to a treatment group.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo IVF or ICSI with photobiomodulation (PBM) treatment to improve embryo growth and pregnancy chances

Up to 7 days post egg retrieval
Daily monitoring during embryo culture

Follow-up

Participants are monitored for pregnancy outcomes, including implantation, clinical pregnancy, and live birth rates

Up to 2 years post egg retrieval

What Are the Treatments Tested in This Trial?

Interventions

  • Photobiomodulation

Trial Overview

The HELIOS trial is exploring whether photobiomodulation, a type of red light therapy that boosts cell energy production, can improve embryo growth and increase pregnancy chances during in vitro fertilization.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PhotobiomodulationExperimental Treatment1 Intervention
Group II: No photobiomodulationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Citations

Low-Level Laser Therapy for Improvement of In Vitro ...

The laser treatment group showed higher rates of biochemical and clinical pregnancies at 46.7% and 33.3%, respectively, compared to the control group, which had ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39051002/

Low-Level Laser Therapy for Improvement of In Vitro ...

This study represents the first single-blinded randomized clinical trial to assess the effectiveness of LLLT pretreatment in individuals with RIF.

The Efficacy of Multiwavelength Red and Near-Infrared ...

Our study demonstrated that multiwavelength of red and NIR PBM with either an LED or laser, or a combination, improved female fertility and reproductive health.

PhotoBioModulation (Low Level Laser) for Infertility

PBM offers a natural and non-invasive treatment option for women facing reproductive health issues, with no side effects.

(PDF) Low-Level Laser Therapy for Improvement of In Vitro ...

Our investigation endeavors to assess the effect of low-level laser therapy (LLLT) on pregnancy outcomes in individuals who have undergone a ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39685560/

The Efficacy of Multiwavelength Red and Near-Infrared ...

The present clinical case series study aimed to evaluate the efficacy of multiple wavelengths of red and near-infrared (NIR) laser ...

Photobiomodulation in Complex Female Infertility Profile

The observations helped to inform and establish the following: (1) any adverse effects; (2) the possibility of producing an effective PBM protocol; and (3) a ...

P-191 The use of near-infrared photobiomodulation therapy to ...

Laser irradiation improves cell cycle progression after r-IVM of germinal vesicles (GV) and metaphase I (MI) oocytes through increased mitochondrial metabolism.

Study Details | NCT07311928 | HELIOS: Human Embryo ...

This study will test whether adding this light treatment during in vitro fertilization (IVF) can improve embryo growth and pregnancy chances.

Wavelength-Dependent Regulation of Nitric Oxide Levels and ...

This study explored whether exposure to specific types of light, known as photobiomodulation therapy, could improve sperm energy production and movement.