Clinical trial NCT04528498: Embryo Health Study
Official title: The Embryo Health Study: Prospective Longitudinal Analysis of PGT-P
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Hereditary Diseases
Lead sponsor: Genomic Prediction Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing IVF with preimplantation genetic testing for aneuploidies (PGT-A).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients' interest in Preimplantation Genetic Testing for Polygenic Disorders
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: North Brunswick
country: United States
facility: Genomic Prediction Clinical Laboratory
state: New Jersey
Study officials:
References: