Embryo Health Study (EHS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04528498|
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : March 15, 2022
|Condition or disease||Intervention/treatment|
|Infertility Hereditary Diseases||Other: Preimplantation Genetic Testing|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||The Embryo Health Study: Prospective Longitudinal Analysis of PGT-P|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
- 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.
- Patients' interest in Preimplantation Genetic Testing for Polygenic Disorders [ Time Frame: 2 years ]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".
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528498
|Contact: Nathan Treff, PhD||(973) email@example.com|
|Contact: Diego Marin, PhD||(973) firstname.lastname@example.org|
|United States, New Jersey|
|Genomic Prediction Clinical Laboratory||Recruiting|
|North Brunswick, New Jersey, United States, 08902|
|Contact: Nathan R Treff, PhD 973-529-4284 email@example.com|
|Contact: Diego Marin, PhD 2012333199 ext Treff firstname.lastname@example.org|
|Principal Investigator: Nathan Treff, PhD|