Follow-up With Preimplantation Genetic Testing Patients

Follow-up With Preimplantation Genetic Testing Patients

Sponsors

Lead Sponsor: Genomic Prediction Inc.

Source 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.

Overall Status Recruiting
Start Date 2020-07-11
Completion Date 2050-12-31
Primary Completion Date 2050-07-11
Study Type Observational
Primary Outcome
Measure Time Frame
Patient perspectives on PGT 2 years
Enrollment 10000
Condition
Intervention

Intervention Type: Other

Intervention Name: Follow-up Interview

Description: Non Applicable

Eligibility

Sampling Method:

Probability Sample

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Overall Official
Last Name Role Affiliation
Nathan R Treff, PhD Principal Investigator Genomic Prediction
Overall Contact

Last Name: Nathan R Treff, PhD

Phone: (973) 529-4223

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Genomic Prediction Clinical Laboratory Nathan R Treff, PhD 973-529-4223 [email protected] Nathan Treff, PhD Principal Investigator
Location Countries

United States

Verification Date

2020-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data Yes
Study Design Info

Observational Model: Other

Time Perspective: Other

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