IVF OutcomesHELIOS-ANCT07425080
HELIOS Advanced: Human Oocyte Illumination to Enhance Development
A study testing Photobiomodulation in people with IVF Outcomes, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF Outcomes
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Use of donor oocytes or gestational carrier
- Concurrent experimental laboratory inventions outside of protocol
- Refusal of randomization or request for non-standard handling
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Fertility Center
New York, New York, 10019
Laura C Gemmell, MD, MSc, 646-756-8282, lg3094@cumc.columbia.edu
Stephanie Morgan, MS, 646-756-8282, sm3415@cumc.columbia.edu
About this study
Official title: HELIOS-Advanced: A Prospective, Staged Dose-Escalation Study of Photobiomodulation to Improve Embryo Development in In Vitro Fertilization
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.
Read the detailed description
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 at the oocyte stage. In a randomized, blinded, sibling-oocyte design, the investigators will test whether PBM improves fertilization rates, 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
- IVF Outcomes
- Being tested
- Photobiomodulation
- Keywords
- Infertility, Embryo arrest, Fertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven days post egg retrieval
Secondary outcomes (20)
Maturity Rate
For insemination cycles, defined as the number of mature oocytes divided by the total number of oocytes retrieved, assessed the day after the retrieval.
Measured: Up to seven days post egg retrieval
Fertilization Rate
The fertilization rate for intracytoplasmic sperm injection (ICSI) cycles is defined as the number of 2PN embryos divided by the number of mature oocytes. For insemination cycles, two fertilization rates will be reported. The first is defined as the number of 2PN embryos divided by the number of cumulus-oocyte-complexes (COC) inseminated. The second is defined as the number of 2PN embryos divided by the number of mature oocytes determined the day after the retrieval.
Measured: Up to seven days post egg retrieval
tPNf
Timing of pronuclei fading defined as the time (hours) for both pronuclei to disappear, signaling the end of the 1-cell stage and beginning the first cell division.
Measured: Up to seven days post egg retrieval
Time to 2-cell stage
Time (hours) for embryo to reach the 2-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to 3-cell stage
Time (hours) for embryo to reach the 3-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to 6-cell stage
Time (hours) for embryo to reach the 6-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to 8-cell stage
Time (hours) for embryo to reach the 8-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to morula
Time (hours) for embryo to reach the morula stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to start of blastulation
Time (hours) for embryo to start blastulation from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to blastocyst
Time (hours) for embryo to reach the blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Time to hatching blastocyst
Time (hours) for embryo to reach the hatching blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging.
Measured: Up to seven days post egg retrieval
Number of good quality blastocysts as defined by Gardner grading system
Final blastocyst quality at the time of cryopreservation (Day 5,6, or 7) will be assessed using the Gardner grading system, which consists of three parameters: expansion and hatching status (graded 1-6), inner cell mass (graded A-D), and trophectoderm (graded A-D). A good quality blastocyst will be defined as a blastocyst of grade 3BB or higher.
Measured: Up to seven days post egg retrieval
Euploidy Rate
The chromosomal ploidy status of cryopreserved blastocysts is assessed by the presence of two copies of each autosome and the expected complement of sex chromosomes. The euploidy rate is defined as the number of cryopreserved blastocysts that have the correct number of chromosomes divided by the total number of cryopreserved blastocysts.
Measured: Within 30 days post egg retrieval
Proportion of Embryo Selected for Transfer
In cases with no stated embryo sex preference, the proportion of cycles in which the embryo selected for transfer is from the PBM-treated group versus the control group will be reported.
Measured: Within 1 year post egg retrieval
Implantation Rate
Implantation rate is defined as the number of cycles with positive beta hCG (human chorionic gonadotropin) nine days or more post frozen embryo transfer divided by the total number of frozen embryo transfer cycles.
Measured: Within 1 year post egg retrieval
Clinical pregnancy rate
Clinical pregnancy rate is defined as the number of cycles with the presence of a gestational sac visualized on transvaginal ultrasound divided by the total number of frozen embryo transfer cycles.
Measured: Within 1 year post egg retrieval
Miscarriage rate
Miscarriage rate is defined as the number of cycles with clinical pregnancy losses divided by the number of cycles that had positive hCGs post frozen embryo transfer.
Measured: Within 1 year of egg retrieval
Live birth rate
Live birth rate is defined as the number of cycles with a live born infant after 24 weeks gestation divided by total number of frozen embryo transfer cycles.
Measured: Up to 2 years post egg retrieval
Gestational Age at Delivery
Total number of completed weeks and days of pregnancy, calculated using frozen embryo transfer date.
Measured: Up to 2 years post egg retrieval
Birthweight
The weight of the baby at birth in grams
Measured: Up to 2 years post egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start24 Mar 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVF OutcomesStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Zev Williams, Columbia University
- Investigators
- Samuel Zev Williams, MD/PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425080
- Sponsor's protocol ID
- ACYY1279
- Acronym
- HELIOS-A
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HELIOS-Advanced: A Prospective, Staged Dose-Escalation Study of Photobiomodulation to Improve Embryo Development in In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT07425080
- Acronym / sponsor ID
- HELIOS-A / ACYY1279
- Conditions
- IVF Outcomes
- Keywords
- Infertility, Embryo arrest, Fertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 24 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 at the oocyte stage. In a randomized, blinded, sibling-oocyte design, the investigators will test whether PBM improves fertilization rates, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: PhotobiomodulationParticipants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant oocytes will be randomized to receive PBM. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Use of donor oocytes or gestational carrier
- Concurrent experimental laboratory inventions outside of protocol
- Refusal of randomization or request for non-standard handling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationPhotobiomodulation (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. | Other | Photobiomodulation |
Primary outcome
Number of usable blastocysts
Time frame: Seven days post egg retrieval
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.
20 secondary outcomes
Maturity Rate
Time frame: Up to seven days post egg retrieval
Fertilization Rate
Time frame: Up to seven days post egg retrieval
tPNf
Time frame: Up to seven days post egg retrieval
Time to 2-cell stage
Time frame: Up to seven days post egg retrieval
Time to 3-cell stage
Time frame: Up to seven days post egg retrieval
Time to 6-cell stage
Time frame: Up to seven days post egg retrieval
Time to 8-cell stage
Time frame: Up to seven days post egg retrieval
Time to morula
Time frame: Up to seven days post egg retrieval
Time to start of blastulation
Time frame: Up to seven days post egg retrieval
Time to blastocyst
Time frame: Up to seven days post egg retrieval
Time to hatching blastocyst
Time frame: Up to seven days post egg retrieval
Number of good quality blastocysts as defined by Gardner grading system
Time frame: Up to seven days post egg retrieval
Euploidy Rate
Time frame: Within 30 days post egg retrieval
Proportion of Embryo Selected for Transfer
Time frame: Within 1 year post egg retrieval
Implantation Rate
Time frame: Within 1 year post egg retrieval
Clinical pregnancy rate
Time frame: Within 1 year post egg retrieval
Miscarriage rate
Time frame: Within 1 year of egg retrieval
Live birth rate
Time frame: Up to 2 years post egg retrieval
Gestational Age at Delivery
Time frame: Up to 2 years post egg retrieval
Birthweight
Time frame: Up to 2 years post egg retrieval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Zev Williams, MD/PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with IVF Outcomes, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Zev Williams, MD, PhD (646-756-8282, zw2421@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of usable blastocysts (time frame: Seven days post egg retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.