Clinical trial NCT06419127: Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Official title: Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility, Female
Infertility, Male
Infertility
IVF
Aneuploidy
Keywords: ivf
infertility
pgt
embryo
Lead sponsor: Gattaca Genomics
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infertile patients undergoing IVF with PGT

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.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing IVF with PGT

Exclusion Criteria:

* patients undergoing IVF and not electing for PGT

Primary outcomes:
measure: Time to first cleavage
timeFrame: 24 hours
measure: Time to blastulation
timeFrame: 5-7 days
measure: Fertilization morphology
timeFrame: 24 hours
measure: Embryo morphology
timeFrame: 2-7 days
measure: Patient age
timeFrame: 0 days
measure: Partner age
timeFrame: 0 days
measure: Patient diagnosis
timeFrame: 0 days
measure: Partner diagnosis
timeFrame: 0 days
measure: Metabolomics of culture media
timeFrame: 7 days
measure: AMH
timeFrame: 0 days
measure: Days of stimulation
timeFrame: 0-15 days
measure: Dosage of stimulation meds
timeFrame: 0-15 days
measure: Pregnancy
timeFrame: 2 weeks after transfer
measure: implantation
timeFrame: 4 weeks post transfer
measure: fetal cardiac heartbeat
timeFrame: 6 weeks
measure: livebirth
timeFrame: approximately 9 months after transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Gattaca Genomics
state: Florida
Study officials:
References: