HELIOS Advanced: Human Oocyte Illumination to Enhance Development
ConditionIVF Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Use of donor oocytes or gestational carrier
Concurrent experimental laboratory inventions outside of protocol
Refusal of randomization or request for non-standard handling
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
Other interventionPhotobiomodulation (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.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: No photobiomodulationNo intervention 0 interventions
Group B: PhotobiomodulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Seven days post egg retrievalSecondary outcomes
1
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.
Time frame
Up to seven days post egg retrieval2
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.
Time frame
Up to seven days post egg retrieval3
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.
Time frame
Up to seven days post egg retrieval4
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.
Time frame
Up to seven days post egg retrievalSponsors and contacts
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Source ClinicalTrials.gov