NCT04528498

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

August 24, 2020

Last Update Submit

August 19, 2025

Conditions

InfertilityHereditary Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Preimplantation Genetic TestingOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing IVF with preimplantation genetic testing for aneuploidies (PGT-A).

You may qualify if:

  • 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.

You may not qualify if:

  • Any case where biological parental DNA is unavailable.
  • Any case involving PGT-M or PGT-SR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, 08902, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Amplified DNA from trophectoderm biopsies of human embryos and from saliva samples.

MeSH Terms

Conditions

InfertilityGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Talia Metzgar, RN

CONTACT

(973) 529-4223Talia@genomicprediction.com

Bhavini Rana

CONTACT

(973) 529-4223bhavini@genomicprediction.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 26, 2025

Record last verified: 2024-08

Locations

US(1)