Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

HELIOS Advanced: Human Embryo Illumination to Enhance Development (HELIOS-A)

5 november 2026 uppdaterad av: Samuel Zev Williams, Columbia University

HELIOS Advanced: Mänsklig Oocyt Belysning för Att Förbättra Utveckling

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

270

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10019
        • Rekrytering
        • Columbia University Fertility Center
        • Huvudutredare:
          • Samuel Z Williams, MD, PhD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 48 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: 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.
Övrig: Photobiomodulation

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of usable blastocysts
Tidsram: 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 per cleavage stage embryo on Day 3.
Seven days post egg retrieval

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to 2-cell stage
Tidsram: 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.
Up to seven days post egg retrieval
Time to 3-cell stage
Tidsram: 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.
Up to seven days post egg retrieval
Time to 6-cell stage
Tidsram: 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.
Up to seven days post egg retrieval
Time to 8-cell stage
Tidsram: 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
Time to morula
Tidsram: 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.
Up to seven days post egg retrieval
Time to start of blastulation
Tidsram: 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
Time to blastocyst
Tidsram: 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
Time to hatching blastocyst
Tidsram: 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
Number of good quality blastocysts as defined by Gardner grading system
Tidsram: 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.
Up to seven days post egg retrieval
Euploidy Rate
Tidsram: 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.
Within 30 days post egg retrieval
Proportion of Embryo Selected for Transfer
Tidsram: 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.
Within 1 year post egg retrieval
Implantation Rate
Tidsram: 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.
Within 1 year post egg retrieval
Clinical pregnancy rate
Tidsram: 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.
Within 1 year post egg retrieval
Miscarriage rate
Tidsram: 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.
Within 1 year of egg retrieval
Live birth rate
Tidsram: 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.
Up to 2 years post egg retrieval
Gestational Age at Delivery
Tidsram: Up to 2 years post egg retrieval

Total number of completed weeks and days of pregnancy, calculated using frozen embryo transfer date.
Up to 2 years post egg retrieval
Birthweight
Tidsram: Up to 2 years post egg retrieval

The weight of the baby at birth in grams
Up to 2 years post egg retrieval

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Columbia University

Utredare

  • Huvudutredare: Samuel Zev Williams, MD/PhD, Columbia University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 mars 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2028

Studieregistreringsdatum

Först inskickad

13 februari 2026

Först inskickad som uppfyllde QC-kriterierna

13 februari 2026

Första postat (Faktisk)

20 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACYY1279

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera