- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04477863
Follow-up With Preimplantation Genetic Testing Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: To perform longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Talia Metzgar, RN
- Phone Number: (973) 529-4223
- Email: Talia@genomicprediction.com
Study Contact Backup
- Name: Bhavini Rana
- Phone Number: (973) 529-4223
- Email: bhavini@genomicprediction.com
Study Locations
-
-
New Jersey
-
North Brunswick, New Jersey, United States, 08902
- Recruiting
- Genomic Prediction Clinical Laboratory
-
Contact:
- Talia Metzgar, RN
- Phone Number: 973-529-4223
- Email: Talia@genomicprediction.com
-
Contact:
- Bhavini Rana
- Phone Number: (973) 529-4223
- Email: bhavini@genomicprediction.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients indicating willingness to participate in research during informed consent to perform PGT
Exclusion Criteria:
- Patients who opted out of participating in research during informed consent to perform PGT
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient perspectives on PGT
Time Frame: 2 years
|
Analysis of interview responses
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathan R Treff, PhD, Genomic Prediction
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Genomic Prediction Inc 609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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