Follow-up With Preimplantation Genetic Testing Patients

Recruiting

• Conditions: Infertility; Genetic Disease; IVF

• Registration Number: NCT04477863
• Lead Sponsor: Genomic Prediction Inc.

Brief 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.

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 Timeline

• Study Start: 2020-07-11
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22
• Primary Completion: 2050-07-11
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient perspectives on PGT	2 years	Analysis of interview responses

Trial Locations

Locations (1)

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