Follow-up With Preimplantation Genetic Testing Patients

G

Genomic Prediction

Status

Enrolling

Conditions

IVF
Infertility
Genetic Disease

Treatments

Other: Follow-up Interview

Study type

Observational

Funder types

Industry

Identifiers

NCT04477863
Genomic Prediction Inc 609

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Talia Metzgar, RN; Bhavini Rana

Data sourced from clinicaltrials.gov

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