Follow-up With Preimplantation Genetic Testing Patients

NCT ID: NCT04477863

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-11

Study Completion Date

2050-12-31

Brief Summary

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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

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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.

Conditions

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Infertility Genetic Disease IVF

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Follow-up Interview

Non Applicable

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genomic Prediction Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan R Treff, PhD

Role: PRINCIPAL_INVESTIGATOR

Genomic Prediction

Locations

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Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Talia Metzgar, RN

Role: CONTACT

(973) 529-4223

Bhavini Rana

Role: CONTACT

(973) 529-4223

Facility Contacts

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Talia Metzgar, RN

Role: primary

(973) 529-4223

Bhavini Rana

Role: backup

(973) 529-4223

Related Links

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Other Identifiers

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Genomic Prediction Inc 609

Identifier Type: -

Identifier Source: org_study_id

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