Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Timelapse incubation and PGT.
- Who it may be relevant to
- Registry conditions: Infertility, Female, Infertility, Male, Infertility, IVF. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Time to first cleavage [Time frame: 24 hours]
- Time to blastulation [Time frame: 5-7 days]
- Fertilization morphology [Time frame: 24 hours]
- Embryo morphology [Time frame: 2-7 days]
- Patient age [Time frame: 0 days]
- Partner age [Time frame: 0 days]
- Partner diagnosis [Time frame: 0 days]
- Metabolomics of culture media [Time frame: 7 days]
- AMH [Time frame: 0 days]
- Days of stimulation [Time frame: 0-15 days]
Eligibility criteria
Inclusion criteria
- all patients undergoing IVF with PGT
Exclusion criteria
- patients undergoing IVF and not electing for PGT
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Gattaca Genomics — Fort Lauderdale
Identifiers
NCT: NCT06419127 · GG1001