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.

Embryo Health Study

Infertility

Hereditary Diseases

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.

Preimplantation Genetic Testing

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

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".

Embryo Health Study

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status