Cell Free Preimplantation Genetic Testing

Not yet recruiting

• Conditions: Infertility, Female; Infertility, Male
• Interventions: Other: Spent media collection

• Registration Number: NCT04628507
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Study Start: 2024-06-11
• Primary Completion: 2024-11-11
• Study Completion: 2024-12-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing IVF	Spent media collection	-

Primary Outcome Measures

Name	Time	Method
Concordance with PGT	14 dyas	Concordance rates with PGT diagnosis from trophectoderm biopsies

Trial Locations

Locations (1)

Genomic Prediction Clinical Laboratory; 🇺🇸 North Brunswick, New Jersey, United States