Cell Free Preimplantation Genetic Testing

NCT ID: NCT04628507

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-11

Study Completion Date

2027-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Consenting patients will receive standard clinical IVF and PGT. Culture media from embryos will be collected for analysis. Collection of media will include laser assisted collapse of the blastocyst on day 5, 6, or 7 in order to release blastocoel fluid into the culture media. Embryos diagnosed as aneuploid or monogenic disorder affected (abnormal embryos) will be donated for additional analysis with patient consent.

Results obtained from culture media will not be provided to the patients. The information obtained from cf-PGT will be compared to results obtained from embryo biopsies obtained as part of routine PGT and evaluated for concordance and reliability. Abnormal embryos will be rebiopsied (\~3 to 4 times) to evaluate concordance with cf-PGT and the original clinical trophectoderm biopsy PGT results.

All cases will be labelled using a 5-digit barcode and embryo number or saliva source code. Because PGT will be conducted under clinical regulatory approval (CAP and CLIA), patient information will be protected under HIPAA guidelines, including sending reports in encrypted secure email per standard operating procedures. All publications and presentations will maintain de-identification of any patient data used.

Patients may withdraw from the study at any time by contacting the principal investigator of their respective recruiting site. They will continue to receive standard of care through their treating IVF center. A recruitment target of 200 patients is intended for this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Female Infertility, Male

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing IVF

Spent media collection

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spent media collection

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genomic Prediction Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Talia Metzgar, RN

Role: CONTACT

9735294223

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Talia Metzgar, RN

Role: primary

9735294223

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Genomic Prediction Inc 632

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.