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Enrolling by Invitation

NCT Number: NCT06419127

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

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.

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Key information

Conditions

Infertility, Female Aneuploidy Chromosome Aberrations Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male IVF Infertility Infertility, Male Long Qt Syndrome 3 Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gattaca Genomics

Fort Lauderdale, Florida, 33308, United States

About this study

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.

Who can participate

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

Inclusion criteria

  • all patients undergoing IVF with PGT

Exclusion criteria

  • patients undergoing IVF and not electing for PGT

Treatment and study plan

Timelapse incubation and PGT

Diagnostic Test

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

Primary outcomes

  1. Time to first cleavage

    Time frame: 24 hours

    time of embryo to undergo first cleavage

  2. Time to blastulation

    Time frame: 5-7 days

    time of embryo to form a blastocoel

  3. Fertilization morphology

    Time frame: 24 hours

    the morphological appearance of the pronuclei

  4. Embryo morphology

    Time frame: 2-7 days

    the morphological appearance of the embryos

  5. Patient age

    Time frame: 0 days

    Patient age

  6. Partner age

    Time frame: 0 days

    Partner age

  7. Partner diagnosis

    Time frame: 0 days

    Partner diagnosis

  8. Metabolomics of culture media

    Time frame: 7 days

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

  9. AMH

    Time frame: 0 days

    antimullerian hormone level in female's blood

  10. Days of stimulation

    Time frame: 0-15 days

    the number of days the patient underwent stimulation for IVF

  11. Dosage of stimulation meds

    Time frame: 0-15 days

    the amount of stimulation meds the patient took during IVF treatment

  12. Pregnancy

    Time frame: 2 weeks after transfer

    initial bhCG levels

  13. Patient diagnosis

    Time frame: 0 days

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

  14. implantation

    Time frame: 4 weeks post transfer

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

  15. fetal cardiac heartbeat

    Time frame: 6 weeks

    Number of patients that develop a fetal cardiac heartbeat after transfer

  16. livebirth

    Time frame: approximately 9 months after transfer

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

Sponsors and collaborators

Lead sponsor

Gattaca Genomics

Industry

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2033
First posted
May 17, 2024
Registry last updated
Jan 29, 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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