NCT04528498

Embryo Health Study

The Embryo Health Study: Prospective Longitudinal Analysis of PGT-P

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Genomic Prediction Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Patients planning to use PGT-A and who meet the inclusion criteria will be offered participation by their IVF physician prior to initiating cycle stimulation. Eligible and interested patients will be contacted, counseled and consented for participation in the study by a Genetic Counselor at Genomic Prediction Clinical Laboratory. This will include genetic counseling to address the benefits and limitations of PGT-A and PGT-P, the family history of diseases currently tested under PGT-P, what diseases they may be interested in testing, the process of obtaining saliva samples, and the information provided by PGT-P results. A total of 500 patients will complete the study and may be recruited from any IVF clinic in the United States. After being enrolled in the study, patients will have two options. One option is to receive PGT-A results first and then decide if they wish to receive the PGT-P results. A second option is to receive a single comprehensive report. All patients will receive a report indicating the predicted karyotype of each embryo (PGT-A) and, according to which option they elected, may also receive a report on any or all of the following elected diseases: Type 1 Diabetes, Type 2 Diabetes, Coronary Artery Disease, Heart Attack, Hypercholesterolemia, Hypertension, Testicular Cancer, Prostate Cancer, Malignant Melanoma, Breast Cancer, Basal Cell Carcinoma. Furthermore, a genetic ancestry test will be performed on each submitted saliva sample to determine potential PGT-P performance and which disease predictors can be computed based on the patients ethnic background.

Conditions

• Infertility
• Hereditary Diseases

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-08-27
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States