NCT04628507

Brief Summary

This study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). Genetic testing of culture media will be compared to conventional methods based on embryo biopsies.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

November 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
5.6 years until next milestone

Study Start

First participant enrolled

June 11, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2027

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

November 9, 2020

Last Update Submit

August 19, 2025

Conditions

Infertility, FemaleInfertility, Male

Keywords

PGTNoninvasive

Outcome Measures

Primary Outcomes (1)

  • Concordance with PGT

    Concordance rates with PGT diagnosis from trophectoderm biopsies

    14 dyas

Study Arms (1)

Patients undergoing IVF

Other: Spent media collection

Interventions

Spent media collectionOTHER

Embryo spent culture media, otherwise discarded as per standard of care, is collected once embryos have completed in vitro culture.

Patients undergoing IVF

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing IVF electing to utilize LifeView testing who consented for embryo spent media collection and analysis.

You may qualify if:

  • Patients undergoing IVF electing to utilize LifeView testing (PGT) will be offered participation in this study.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, 08902, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples, embryo spent culture medium, and leftover amplification product from embryo biopsies.

MeSH Terms

Conditions

Infertility, FemaleInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityGenital Diseases, MaleMale Urogenital Diseases

Central Study Contacts

Talia Metzgar, RN

CONTACT

9735294223Talia@genomicprediction.com

Study Design

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

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 13, 2020

Study Start (Estimated)

June 11, 2026

Primary Completion (Estimated)

November 11, 2027

Study Completion (Estimated)

December 11, 2027

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)