Embryo genetic risk reporting during IVF
The Embryo Health Study: Prospective Longitudinal Analysis of PGT-P
Genomic Prediction Inc. · NCT04528498
People having IVF with PGT-A will be offered optional additional reports showing embryos' polygenic risk for several common diseases after genetic counseling.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genomic Prediction Inc. (industry) |
| Locations | 1 site (North Brunswick, New Jersey) |
| Trial ID | NCT04528498 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll up to 500 patients planning IVF with PGT-A and who meet ancestry and eligibility criteria, with enrollment offered before cycle stimulation. A genetic counselor from the sponsoring laboratory will consent participants, collect saliva for parental ancestry and DNA, and explain the benefits and limitations of both PGT-A and optional polygenic testing (PGT-P). Participants may choose to receive PGT-A results first and then decide about PGT-P, or receive a single combined report listing predicted embryo karyotypes and, if selected, polygenic risk estimates for a set of common diseases. All counseling and laboratory testing are coordinated by Genomic Prediction Clinical Laboratory, with samples processed at their North Brunswick, New Jersey facility.
Who should consider this trial
Good fit: Ideal candidates are couples of Caucasian or East Asian ancestry, aged 18 or older, who plan to have PGT-A as part of their IVF cycle and can provide parental DNA samples.
Not a fit: People of other ancestries, those who cannot provide parental DNA, or cases involving PGT-M or PGT-SR may not benefit from this offering.
Why it matters
Potential benefit: If accepted and used appropriately, the additional polygenic risk information could give prospective parents more data to inform embryo selection and reproductive planning.
How similar studies have performed: Polygenic embryo scoring has been piloted in a few recent programs with preliminary correlations to adult disease risk but remains novel and lacks strong clinical outcome evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
North Brunswick, New Jersey
- Genomic Prediction Clinical Laboratory — North Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Talia Metzgar, RN
- Email: Talia@genomicprediction.com
- Phone: (973) 529-4223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Hereditary Diseases