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

Recruiting

• Conditions: Infertility, Male; Infertility; IVF; Infertility, Female; Aneuploidy

• Registration Number: NCT06419127
• Lead Sponsor: Gattaca Genomics

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Study Start: 2024-06
• Primary Completion: 2027-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• all patients undergoing IVF with PGT

Exclusion Criteria

• patients undergoing IVF and not electing for PGT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient age	0 days	Patient age
Days of stimulation	0-15 days	the number of days the patient underwent stimulation for IVF
livebirth	approximately 9 months after transfer	the livebirth of an infant after IVF
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
Pregnancy	2 weeks after transfer	initial bhCG levels
Fertilization morphology	24 hours	the morphological appearance of the pronuclei
Embryo morphology	2-7 days	the morphological appearance of the embryos
Partner age	0 days	Partner age
Patient diagnosis	0 days	Patient diagnosis
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
Dosage of stimulation meds	0-15 days	the amount of stimulation meds the patient took during IVF treatment
implantation	4 weeks post transfer	development of a sac within the uterus post transfer
fetal cardiac heartbeat	6 weeks	development of fetal cardiac heartbeat after transfer

Trial Locations

Locations (1)

Gattaca Genomics; 🇺🇸 Fort Lauderdale, Florida, United States