270 Participants NeededMy employer runs this trial

Photobiomodulation for In Vitro Fertilization

(HELIOS-A 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 tests a gentle light therapy called photobiomodulation (PBM) to determine its effectiveness in improving outcomes during in vitro fertilization (IVF). As women age, the energy production in their egg cells declines, which can hinder embryo development. PBM uses red light to boost cellular energy, potentially enhancing embryo growth and pregnancy success. Participants undergoing IVF with their own eggs might be suitable, especially if they have at least two eggs available for the study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance IVF success.

Will I have to stop taking my current medications?

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 (PBM), a gentle light therapy, is generally safe for people. Studies have found that using red and near-infrared light in PBM can boost cellular energy without causing harm. For example, one study discovered that this light increased energy production in sperm cells without any damage. Another study demonstrated improved fertility outcomes, indicating safety for reproductive health. Overall, these findings suggest PBM is a safe treatment option, with no major side effects reported.12345

Why are researchers excited about this trial?

Photobiomodulation is unique because it uses light therapy to potentially enhance the success of in vitro fertilization (IVF), a process that typically relies on hormonal treatments and lab techniques to assist reproduction. Unlike standard IVF treatments, which focus primarily on manipulating the biological environment chemically or physically, photobiomodulation introduces a non-invasive approach that leverages light to stimulate cellular activity and improve egg quality. Researchers are excited about this technique because it represents a novel mechanism of action that could increase the chances of successful fertilization and implantation without additional drugs or invasive procedures.

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

Research has shown that photobiomodulation (PBM), a type of red light therapy, may improve fertility. In one study, 46.7% of women who received PBM had higher pregnancy rates compared to those who did not. Another study found that 66% of participants became pregnant within one to three months after PBM treatment. This therapy appears to boost energy production in cells, which is crucial for developing healthy eggs and embryos. Studies on animals and early clinical trials suggest that PBM can enhance embryo growth and increase the number of healthy early-stage embryos, known as blastocysts. In this trial, participants will be randomized into two groups: one group will receive PBM as part of their IVF treatment, while the other group will not. These findings suggest that PBM could be a promising addition to fertility treatments like in vitro fertilization (IVF).14567

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, who have at least two eggs available and plan to transfer a healthy embryo within 6 months. It excludes those using donor eggs or surrogates, or not willing to follow the study's procedures.

Inclusion Criteria

Undergoing blastocyst culture
Using own oocytes
Has at least two oocytes available for randomization
See 3 more

Exclusion Criteria

Use of donor oocytes or gestational carrier
Concurrent experimental laboratory inventions outside of protocol
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/ICSI cycles with PGT-A, with oocytes randomized to receive or not receive photobiomodulation (PBM)

Up to 7 days post egg retrieval
Daily monitoring during IVF/ICSI cycle

Follow-up

Participants are monitored for embryo development stages and pregnancy outcomes

Up to 2 years post egg retrieval
Regular follow-up visits for pregnancy monitoring

Long-term Follow-up

Monitoring of live birth rate, gestational age at delivery, and birthweight

Up to 2 years post egg retrieval

What Are the Treatments Tested in This Trial?

Interventions

  • Photobiomodulation

Trial Overview

The study tests whether exposing eggs to a gentle red light treatment (photobiomodulation) during IVF can improve embryo development and pregnancy rates. Eggs are randomly assigned to receive this light therapy or standard care.

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

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

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 for In Vitro Fertilization - (HELIOS Trial)

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 ...

Photobiomodulation in Complex Female Infertility Profile

However, to date there is no published data to explore how PBM can improve the fertility outcomes of women younger than 35, who fail to conceive as a result of ...

Photobiomodulation and Red Light Therapy for Fertility

66% of participants achieved pregnancy within 1-3 months of PBM treatment. These results indicate that PBM could be a powerful adjunct to conventional fertility ...

5.

pubmed.ncbi.nlm.nih.gov

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

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.

The impact of near-infrared photobiomodulation therapy on ...

Our findings demonstrate that PBMT enhances cell cycle progression of GV and MI oocytes by activating mitochondrial metabolism. The improved ...

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.