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NCT04477863 Clinical Trial

Follow-up With Preimplantation Genetic Testing Patients

Infertility Clinical Trial

Official title:
Follow-up With Preimplantation Genetic Testing Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04477863
Other study ID # Genomic Prediction Inc 609
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 11, 2020
Est. completion date December 31, 2050

Study information
Verified date February 2023
Source Genomic Prediction Inc.
Contact Talia Metzgar, RN
Phone (973) 529-4223
Email Talia@genomicprediction.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (PGT). Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded interview.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 31, 2050
Est. primary completion date July 11, 2050
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Follow-up Interview
Non Applicable

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 Patient perspectives on PGT Analysis of interview responses 2 years
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