Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

Infertility Clinical Trial

Official title:

Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419127
• Other study ID #: GG1001
• Status: Recruiting
• Start date: June 2024
• Est. completion date: June 2029

Study information

• Verified date: May 2024
• Source: Gattaca Genomics
• Contact: Tyl H taylor
• Phone: 9806130105
• Email: tyl.taylor[@]gattacagenomics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2029
• Est. primary completion date: June 2027
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• all patients undergoing IVF with PGT

Exclusion Criteria:

• patients undergoing IVF and not electing for PGT

Related Conditions & MeSH terms

• Aneuploidy
• Infertility
• Infertility, Female
• Infertility, Male
• IVF

Intervention

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.

Locations

Country	Name	City	State
United States	Gattaca Genomics	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gattaca Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first cleavage	time of embryo to undergo first cleavage	24 hours
Primary	Time to blastulation	time of embryo to form a blastocoel	5-7 days
Primary	Fertilization morphology	the morphological appearance of the pronuclei	24 hours
Primary	Embryo morphology	the morphological appearance of the embryos	2-7 days
Primary	Patient age	Patient age	0 days
Primary	Partner age	Partner age	0 days
Primary	Patient diagnosis	Patient diagnosis	0 days
Primary	Partner diagnosis	Partner diagnosis	0 days
Primary	Metabolomics of culture media	measurement of the spent culture media for amino acids, enzymes, and metabolites	7 days
Primary	AMH	antimullerian hormone level in female's blood	0 days
Primary	Days of stimulation	the number of days the patient underwent stimulation for IVF	0-15 days
Primary	Dosage of stimulation meds	the amount of stimulation meds the patient took during IVF treatment	0-15 days
Primary	Pregnancy	initial bhCG levels	2 weeks after transfer
Primary	implantation	development of a sac within the uterus post transfer	4 weeks post transfer
Primary	fetal cardiac heartbeat	development of fetal cardiac heartbeat after transfer	6 weeks
Primary	livebirth	the livebirth of an infant after IVF	approximately 9 months after transfer