Follow-up With Preimplantation Genetic Testing Patients

Sponsor
Genomic Prediction Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04477863
Collaborator
(none)
10,000
1
365.7
27.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Follow-up 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 Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Follow-up With Preimplantation Genetic Testing Patients
Actual Study Start Date :
Jul 11, 2020
Anticipated Primary Completion Date :
Jul 11, 2050
Anticipated Study Completion Date :
Dec 31, 2050

Outcome Measures

Primary Outcome Measures

  1. Patient perspectives on PGT [2 years]

    Analysis of interview responses

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Genomic Prediction Clinical Laboratory North Brunswick New Jersey United States 08902

Sponsors and Collaborators

  • Genomic Prediction Inc.

Investigators

  • Principal Investigator: Nathan R Treff, PhD, Genomic Prediction

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Genomic Prediction Inc.
ClinicalTrials.gov Identifier:
NCT04477863
Other Study ID Numbers:
  • Genomic Prediction Inc 609
First Posted:
Jul 20, 2020
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Genomic Prediction Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022