Cell Free Preimplantation Genetic Testing

Infertility, Female Clinical Trial

Official title:

Evaluation of Cell Free Preimplantation Genetic Testing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04628507
• Other study ID #: Genomic Prediction Inc 632
• Status: Not yet recruiting
• Start date: June 11, 2024
• Est. completion date: December 11, 2024

Study information

• Verified date: November 2023
• Source: Genomic Prediction Inc.
• Contact: Talia Metzgar, RN
• Phone: 9735294223
• Email: Talia[@]genomicprediction.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 11, 2024
• Est. primary completion date: November 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility, Male

Intervention

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

Locations

Country	Name	City	State
United States	Genomic Prediction Clinical Laboratory	North Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Genomic Prediction Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance with PGT	Concordance rates with PGT diagnosis from trophectoderm biopsies	14 dyas