Cell Free Preimplantation Genetic Testing

Sponsor

Genomic Prediction Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04628507

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Infertility, Male	Other: Spent media collection

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Cell Free Preimplantation Genetic Testing

Anticipated Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Nov 11, 2023

Anticipated Study Completion Date :

Dec 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients undergoing IVF	Other: Spent media collection Embryo spent culture media, otherwise discarded as per standard of care, is collected once embryos have completed in vitro culture.

Arm

Intervention/Treatment

Patients undergoing IVF

Other: Spent media collection

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

Outcome Measures

Primary Outcome Measures

Concordance with PGT [14 dyas]
Concordance rates with PGT diagnosis from trophectoderm biopsies

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genomic Prediction Clinical Laboratory	North Brunswick	New Jersey	United States	08902

Sponsors and Collaborators

Genomic Prediction Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genomic Prediction Inc.

ClinicalTrials.gov Identifier:

NCT04628507

Other Study ID Numbers:

Genomic Prediction Inc 632

First Posted:

Nov 13, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Genomic Prediction Inc.

PGT

Noninvasive

Additional relevant MeSH terms:

Infertility

Infertility, Female

Infertility, Male

Study Results

No Results Posted as of Mar 15, 2022