Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Overview
- Phase
- Not Applicable
- Intervention
- Timelapse incubation and PGT
- Conditions
- Infertility, Female
- Sponsor
- Gattaca Genomics
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Patient age
- Status
- Enrolling By Invitation
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •all patients undergoing IVF with PGT
Exclusion Criteria
- •patients undergoing IVF and not electing for PGT
Arms & Interventions
Infertile patients
Infertile patients undergoing IVF with PGT.
Intervention: Timelapse incubation and PGT
Outcomes
Primary Outcomes
Patient age
Time Frame: 0 days
Patient age
Days of stimulation
Time Frame: 0-15 days
the number of days the patient underwent stimulation for IVF
Time to first cleavage
Time Frame: 24 hours
time of embryo to undergo first cleavage
Time to blastulation
Time Frame: 5-7 days
time of embryo to form a blastocoel
Pregnancy
Time Frame: 2 weeks after transfer
initial bhCG levels
Fertilization morphology
Time Frame: 24 hours
the morphological appearance of the pronuclei
Embryo morphology
Time Frame: 2-7 days
the morphological appearance of the embryos
Partner age
Time Frame: 0 days
Partner age
Partner diagnosis
Time Frame: 0 days
Partner diagnosis
Metabolomics of culture media
Time Frame: 7 days
measurement of the spent culture media for amino acids, enzymes, and metabolites
AMH
Time Frame: 0 days
antimullerian hormone level in female's blood
Dosage of stimulation meds
Time Frame: 0-15 days
the amount of stimulation meds the patient took during IVF treatment
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.
implantation
Time Frame: 4 weeks post transfer
Number of patients that develope a sac within the uterus post transfer
fetal cardiac heartbeat
Time Frame: 6 weeks
Number of patients that develop a fetal cardiac heartbeat after transfer
livebirth
Time Frame: approximately 9 months after transfer
Number of patients that have a livebirth of an infant after IVF