HELIOS Advanced: Human Embryo Illumination to Enhance Development (HELIOS-A)
HELIOS Advanced: Iluminación de Ovocitos Humanos para Mejorar el Desarrollo
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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-embryo 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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samuel Zev Williams, MD, PhD
- Número de teléfono: 646-756-8282
- Correo electrónico: zw2421@cumc.columbia.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10019
- Reclutamiento
- Columbia University Fertility Center
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Investigador principal:
- Samuel Z Williams, MD, PhD
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Contacto:
- Stephanie Morgan, MS
- Número de teléfono: 646-756-8282
- Correo electrónico: sm3415@cumc.columbia.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 cleavage stage embryos available for randomization on Day 3 of embryo development
- Consenting to embryo 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: No photobiomodulation
Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant cleavage stage embryos will be randomized to not receive PBM. |
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Experimental: Photobiomodulation
Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant cleavage stage embryos will be randomized to receive PBM. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of usable blastocysts
Periodo de tiempo: Seven days post egg retrieval
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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 per cleavage stage embryo on Day 3. |
Seven days post egg retrieval
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to 2-cell stage
Periodo de tiempo: Up to seven days post egg retrieval
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Time (hours) for embryo to reach the 2-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Time to 3-cell stage
Periodo de tiempo: Up to seven days post egg retrieval
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Time (hours) for embryo to reach the 3-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Time to 6-cell stage
Periodo de tiempo: Up to seven days post egg retrieval
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Time (hours) for embryo to reach the 6-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Time to 8-cell stage
Periodo de tiempo: 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. |
Up to seven days post egg retrieval
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Time to morula
Periodo de tiempo: Up to seven days post egg retrieval
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Time (hours) for embryo to reach the morula stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Time to start of blastulation
Periodo de tiempo: 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. |
Up to seven days post egg retrieval
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Time to blastocyst
Periodo de tiempo: 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. |
Up to seven days post egg retrieval
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Time to hatching blastocyst
Periodo de tiempo: 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. |
Up to seven days post egg retrieval
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Number of good quality blastocysts as defined by Gardner grading system
Periodo de tiempo: Up to seven days post egg retrieval
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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. |
Up to seven days post egg retrieval
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Euploidy Rate
Periodo de tiempo: Within 30 days post egg retrieval
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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. |
Within 30 days post egg retrieval
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Proportion of Embryo Selected for Transfer
Periodo de tiempo: Within 1 year post egg retrieval
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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. |
Within 1 year post egg retrieval
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Implantation Rate
Periodo de tiempo: Within 1 year post egg retrieval
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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. |
Within 1 year post egg retrieval
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Clinical pregnancy rate
Periodo de tiempo: Within 1 year post egg retrieval
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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. |
Within 1 year post egg retrieval
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Miscarriage rate
Periodo de tiempo: Within 1 year of egg retrieval
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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. |
Within 1 year of egg retrieval
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Live birth rate
Periodo de tiempo: Up to 2 years post egg retrieval
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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. |
Up to 2 years post egg retrieval
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Gestational Age at Delivery
Periodo de tiempo: Up to 2 years post egg retrieval
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Total number of completed weeks and days of pregnancy, calculated using frozen embryo transfer date. |
Up to 2 years post egg retrieval
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Birthweight
Periodo de tiempo: Up to 2 years post egg retrieval
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The weight of the baby at birth in grams |
Up to 2 years post egg retrieval
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samuel Zev Williams, MD/PhD, Columbia University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ACYY1279
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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