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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Infertility; Aneuploidy; Infertility, Female; Infertility, Male; IVF
• Intervention / Treatment: Diagnostic test: Timelapse incubation and PGT

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Gattaca Genomics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All infertile patients undergoing IVF with PGT

Description

Inclusion Criteria:

• all patients undergoing IVF with PGT

Exclusion Criteria:

• patients undergoing IVF and not electing for PGT

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infertile patients; Infertile patients undergoing IVF with PGT.	Diagnostic test: Timelapse 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first cleavage	time of embryo to undergo first cleavage	24 hours
Time to blastulation	time of embryo to form a blastocoel	5-7 days
Fertilization morphology	the morphological appearance of the pronuclei	24 hours
Embryo morphology	the morphological appearance of the embryos	2-7 days
Patient age	Patient age	0 days
Partner age	Partner age	0 days
Partner diagnosis	Partner diagnosis	0 days
Metabolomics of culture media	measurement of the spent culture media for amino acids, enzymes, and metabolites	7 days
AMH	antimullerian hormone level in female's blood	0 days
Days of stimulation	the number of days the patient underwent stimulation for IVF	0-15 days
Dosage of stimulation meds	the amount of stimulation meds the patient took during IVF treatment	0-15 days
Pregnancy	initial bhCG levels	2 weeks after transfer
Patient diagnosis	Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility.	0 days
implantation	Number of patients that develope a sac within the uterus post transfer	4 weeks post transfer
fetal cardiac heartbeat	Number of patients that develop a fetal cardiac heartbeat after transfer	6 weeks
livebirth	Number of patients that have a livebirth of an infant after IVF	approximately 9 months after transfer

Collaborators and Investigators

• Sponsor: Gattaca Genomics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2033

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: infertility; embryo; ivf; pgt
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Chromosome Aberrations; Pathological Conditions, Signs and Symptoms; Infertility; Infertility, Female; Infertility, Male; Aneuploidy; Long Qt Syndrome 3
• Other Study ID Numbers: GG1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No