Aneuploidy, Infertility, Infertility, Female, Infertility, Male, IVF
Conditions
Keywords
ivf, infertility, pgt, embryo
Brief 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.
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_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.
Sponsors
Gattaca Genomics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Inclusion criteria
* all patients undergoing IVF with PGT
Exclusion criteria
* patients undergoing IVF and not electing for PGT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first cleavage | 24 hours | time of embryo to undergo first cleavage |
| Time to blastulation | 5-7 days | time of embryo to form a blastocoel |
| Fertilization morphology | 24 hours | the morphological appearance of the pronuclei |
| Embryo morphology | 2-7 days | the morphological appearance of the embryos |
| Patient age | 0 days | Patient age |
| Partner age | 0 days | Partner age |
| Partner diagnosis | 0 days | Partner diagnosis |
| Metabolomics of culture media | 7 days | measurement of the spent culture media for amino acids, enzymes, and metabolites |
| AMH | 0 days | antimullerian hormone level in female's blood |
| Days of stimulation | 0-15 days | the number of days the patient underwent stimulation for IVF |
| Dosage of stimulation meds | 0-15 days | the amount of stimulation meds the patient took during IVF treatment |
| Pregnancy | 2 weeks after transfer | initial bhCG levels |
| Patient diagnosis | 0 days | Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility. |
| implantation | 4 weeks post transfer | Number of patients that develope a sac within the uterus post transfer |
| fetal cardiac heartbeat | 6 weeks | Number of patients that develop a fetal cardiac heartbeat after transfer |
| livebirth | approximately 9 months after transfer | Number of patients that have a livebirth of an infant after IVF |
Countries
United States
Outcome results
None listed