Recruiting

Observational StudyEmbryo Health Study

Sponsor:

Genomic Prediction Inc.

Code:

NCT04528498

Conditions

Infertility

Hereditary Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Preimplantation Genetic Testing

Study Details

Brief summary:

This study intends to determine the patients' perception and motivation to obtain additional information on their preimplantation embryos' risks of polygenic disorders. Patients undergoing IVF and genetic testing on their embryos for aneuploidies will be given the option to obtain information of their embryos' polygenic disease risk after receiving genetic counseling.

Conditions

Infertility

Hereditary Diseases

Study ID

NCT04528498

Start date

Dec 1, 2020

Status verified date

Aug, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

All couples of Caucasian or East Asian ancestry above the age of 18 who elect to have PGT-A as part of their IVF treatment cycle.

Exclusion Criteria:

Any case where biological parental DNA is unavailable.
Any case involving PGT-M or PGT-SR.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Preimplantation Genetic Testing

Embryo biopsies will undergo preimplantation genetic testing for aneuploidies as per standard of care, and polygenic disease risk (PGT-P) will be computed for these samples.

Primary outcome measure

Patients' interest in Preimplantation Genetic Testing for Polygenic Disorders [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Talia Metzgar, RN

(973) 529-4223 Talia@genomicprediction.com

Bhavini Rana

(973) 529-4223 bhavini@genomicprediction.com

Locations

Genomic Prediction Clinical Laboratory

Recruiting

North Brunswick, New Jersey, United States, 08902

Contacts

Talia Metzgar, RN

talia@genomicprediction.com

Bhavini Rana

bhavini@genomicprediction.com

Principal Investigator:

Nathan Treff, PhD

More Information

Sponsor

Genomic Prediction Inc.

Last update posted

Aug 26, 2025

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genomic Prediction Inc. on 2025-08-26.