Clinical trial NCT04477863: Follow-up With Preimplantation Genetic Testing Patients
Official title: Follow-up With Preimplantation Genetic Testing Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Genetic Disease
IVF
Keywords: PGT
Follow-up
Lead sponsor: Genomic Prediction Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo IVF and Preimplantation Genetic Testing

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient perspectives on PGT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: North Brunswick
country: United States
facility: Genomic Prediction Clinical Laboratory
state: New Jersey
Study officials:
affiliation: Genomic Prediction
name: Nathan R Treff, PhD
role: PRINCIPAL_INVESTIGATOR
References: