Cell Free Preimplantation Genetic Testing

Evaluation of Cell Free Preimplantation Genetic Testing


Lead Sponsor: Genomic Prediction Inc.

Source Genomic Prediction Inc.
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.

Detailed Description

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.

Overall Status Not yet recruiting
Start Date 2023-01-11
Completion Date 2023-12-11
Primary Completion Date 2023-11-11
Study Type Observational
Primary Outcome
Measure Time Frame
Concordance with PGT 14 dyas
Enrollment 200

Intervention Type: Other

Intervention Name: Spent media collection

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

Arm Group Label: Patients undergoing IVF


Sampling Method:

Probability Sample


Inclusion Criteria: - Patients undergoing IVF electing to utilize LifeView testing (PGT) will be offered participation in this study. Exclusion Criteria: - None



Minimum Age:


Maximum Age:


Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Facility: Contact: Genomic Prediction Clinical Laboratory Leslie Duffy 973-529-4223 [email protected]
Location Countries

United States

Verification Date


Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Patients undergoing IVF

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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