Follow-up With Preimplantation Genetic Testing Patients
NCT ID: NCT04477863
Last Updated: 2025-08-26
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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RECRUITING
10000 participants
OBSERVATIONAL
2020-07-11
2050-12-31
Brief Summary
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Detailed Description
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Background: Preimplantation Genetic Testing (PGT) is a commercially available adjunct to in vitro fertilization (IVF) and is now performed in over 40% of treatment cycles in the United Sates (Society for Assisted Reproductive Technology Annual Report, 2018). Several clinical genetics entities offer PGT services, including Genomic Prediction Clinical Laboratory (CLIA# 31D2152380, CAP# 8488628). It is common practice to perform interviews with, and record reviews of patients following clinical interventions. Results may provide instrumental information for the scientific and medical community to improve clinical care. We would like to review medical records in order to recruit patients to participate in longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.
Study Design and Methods: Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. Patients who opted out of participating in research during informed consent to perform PGT will be ineligible for inclusion. Clinical PGT consent forms will be reviewed to identify patients that indicated willingness to participate in research. Eligible patients will be counseled on the study and consented for participation by a licensed genetic counselor. A total of 10,000 patients will be recruited. Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings. As it is in standard practice, all external communication of results will maintain de-identification of all protected health information of all subjects (HIPAA guidelines). A licensed genetic counselor will conduct a recorded interview. Patient PGT, family history, and ethnicity data and information may be included in cohort analyses.
Conditions
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Study Design
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OTHER
OTHER
Interventions
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Follow-up Interview
Non Applicable
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Genomic Prediction Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan R Treff, PhD
Role: PRINCIPAL_INVESTIGATOR
Genomic Prediction
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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Related Links
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SART Preliminary National Summary Report for 2018
Other Identifiers
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Genomic Prediction Inc 609
Identifier Type: -
Identifier Source: org_study_id
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