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NCT Number: NCT07425080

HELIOS Advanced: Human Oocyte Illumination to Enhance Development

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.

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Key information

Conditions

IVF Outcomes Genital Diseases Infertility Urogenital Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Use of donor oocytes or gestational carrier
  • Concurrent experimental laboratory inventions outside of protocol
  • Refusal of randomization or request for non-standard handling

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maturity Rate

    Time frame: Up to seven days post egg retrieval

    For insemination cycles, defined as the number of mature oocytes divided by the total number of oocytes retrieved, assessed the day after the retrieval.

  2. Fertilization Rate

    Time frame: Up to seven days post egg retrieval

    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.

  3. tPNf

    Time frame: Up to seven days post egg retrieval

    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.

  4. Time to 2-cell stage

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the 2-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  5. Time to 3-cell stage

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the 3-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  6. Time to 6-cell stage

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the 6-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  7. Time to 8-cell stage

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the 8-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  8. Time to morula

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the morula stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  9. Time to start of blastulation

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to start blastulation from insemination/ICSI as assessed by embryology using time-lapse imaging.

  10. Time to blastocyst

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  11. Time to hatching blastocyst

    Time frame: Up to seven days post egg retrieval

    Time (hours) for embryo to reach the hatching blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging.

  12. Number of good quality blastocysts as defined by Gardner grading system

    Time frame: Up to seven days post egg retrieval

    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.

  13. Euploidy Rate

    Time frame: Within 30 days post egg retrieval

    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.

  14. Proportion of Embryo Selected for Transfer

    Time frame: Within 1 year post egg retrieval

    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.

  15. Implantation Rate

    Time frame: Within 1 year post egg retrieval

    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.

  16. Clinical pregnancy rate

    Time frame: Within 1 year post egg retrieval

    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.

  17. Miscarriage rate

    Time frame: Within 1 year of egg retrieval

    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.

  18. Live birth rate

    Time frame: Up to 2 years post egg retrieval

    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.

  19. Gestational Age at Delivery

    Time frame: Up to 2 years post egg retrieval

    Total number of completed weeks and days of pregnancy, calculated using frozen embryo transfer date.

  20. Birthweight

    Time frame: Up to 2 years post egg retrieval

    The weight of the baby at birth in grams

Study contacts

Contact information is provided by the study sponsor or research team.

Laura C Gemmell, MD, MSc

CONTACT

[email protected]

646-756-8282

Samuel Zev Williams, MD, PhD

CONTACT

[email protected]

646-756-8282

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

HELIOS-Advanced: A Prospective, Staged Dose-Escalation Study of Photobiomodulation to Improve Embryo Development in In Vitro Fertilization

Acronym: HELIOS-A

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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