ClinicalTrials.gg
Enrolling by invitationNCT06419127Updated Jan 29, 2026

Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

An observational study in Infertility, Female, Infertility, Male and Infertility, sponsored by Gattaca Genomics. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Gattaca Genomics · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results.

Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.

Read the detailed description

Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer.

To date, no one has combined the data from both tools to try to advance the IVF field.

Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.

02

Conditions studied

  • Infertility, Female
  • Infertility, Male
  • Infertility
  • IVF
  • Aneuploidy

Keywords

  • ivf
  • infertility
  • pgt
  • embryo
03

In context

Infertility, Female

552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 161 across 162 observational studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

This is the only study on the registry with Gattaca Genomics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All infertile patients undergoing IVF with PGT

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients undergoing IVF with PGT

Exclusion criteria

Exclusion Criteria:

  • patients undergoing IVF and not electing for PGT
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Infertile patients

    Infertile patients undergoing IVF with PGT.

    Diagnostic Test: Timelapse incubation and PGT

Interventions

  • Diagnostic testTimelapse incubation and PGT

    Patients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation.

06

What researchers measure

Primary outcomes

  1. Time to first cleavage

    time of embryo to undergo first cleavage

    Time frame: 24 hours

  2. Time to blastulation

    time of embryo to form a blastocoel

    Time frame: 5-7 days

  3. Fertilization morphology

    the morphological appearance of the pronuclei

    Time frame: 24 hours

  4. Embryo morphology

    the morphological appearance of the embryos

    Time frame: 2-7 days

  5. Patient age

    Patient age

    Time frame: 0 days

  6. Partner age

    Partner age

    Time frame: 0 days

  7. Partner diagnosis

    Partner diagnosis

    Time frame: 0 days

  8. Metabolomics of culture media

    measurement of the spent culture media for amino acids, enzymes, and metabolites

    Time frame: 7 days

  9. AMH

    antimullerian hormone level in female's blood

    Time frame: 0 days

  10. Days of stimulation

    the number of days the patient underwent stimulation for IVF

    Time frame: 0-15 days

  11. Dosage of stimulation meds

    the amount of stimulation meds the patient took during IVF treatment

    Time frame: 0-15 days

  12. Pregnancy

    initial bhCG levels

    Time frame: 2 weeks after transfer

  13. Patient diagnosis

    Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility.

    Time frame: 0 days

  14. implantation

    Number of patients that develope a sac within the uterus post transfer

    Time frame: 4 weeks post transfer

  15. fetal cardiac heartbeat

    Number of patients that develop a fetal cardiac heartbeat after transfer

    Time frame: 6 weeks

  16. livebirth

    Number of patients that have a livebirth of an infant after IVF

    Time frame: approximately 9 months after transfer

07

Study locations

1 site
  • Gattaca Genomics
    Fort Lauderdale, Florida 33308, United States
08

References and documents

Individual participant data

Plan to share: No — Data will not be shared with other researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Jun 2031, 77 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2024
First posted
May 17, 2024
StartActual
Jan 1, 2025
Primary completionEst.
Jun 2031
CompletionEst.
Jun 2033
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06419127
Lead sponsor
Gattaca Genomics
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Jan 1, 2025
Primary completion
Jun 2031 (estimated)
Completion
Jun 2033 (estimated)
Last update
Jan 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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