Embryo Health Study

Infertility Clinical Trial

— EHS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04528498
• Other study ID #: Genomic Prediction Inc 616
• Status: Active, not recruiting
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Genomic Prediction Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Hereditary Diseases
• Infertility

Intervention

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.

Locations

Country	Name	City	State
United States	Genomic Prediction Clinical Laboratory	North Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Genomic Prediction Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' interest in Preimplantation Genetic Testing for Polygenic Disorders	Patients' interest in obtaining information on their embryos' polygenic disease risk will be measured in a scale of 1-5. 1 being "Not interested" and 5 "highly interested".	2 years