Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2026-06-11
2027-12-11
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients undergoing IVF
Spent media collection
Embryo spent culture media, otherwise discarded as per standard of care, is collected once embryos have completed in vitro culture.
Interventions
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Spent media collection
Embryo spent culture media, otherwise discarded as per standard of care, is collected once embryos have completed in vitro culture.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Genomic Prediction Inc.
INDUSTRY
Responsible Party
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Locations
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Genomic Prediction Clinical Laboratory
North Brunswick, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Genomic Prediction Inc 632
Identifier Type: -
Identifier Source: org_study_id
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