Preimplantation Genetic Testing for Aneuploidy Counseling (PGT-A)

December 19, 2024 updated by: Eyup Hakan Duran

Preimplantation Genetic Testing for Aneuploidy (PGT-A) Counseling for Patients Undergoing in Vitro Fertilization (IVF)

Purpose: To evaluate preimplantation genetic testing counseling interventions on patients undergoing in vitro fertilization treatment.

Preimplantation genetic testing for aneuploidy (PGT) allows patients undergoing in vitro fertilization (IVF) to screen embryos for genetic disorders. Preimplantation genetic testing for aneuploidy (PGT-A) is the testing most commonly ordered, and it screens for whole chromosome and large partial chromosome duplications or deletions. Currently, patient counseling varies based on the clinic, ranging from appointments to group seminars with a genetic counselor (GC), geneticist or reproductive endocrinology and infertility (REI) physicians for education regarding PGT. Patient knowledge regarding PGT has been varied with some studies indicating sufficient knowledge, while other studies have shown a potential lack of knowledge. One study indicated a third of patients had regret regarding their decision of whether or not to use PGT-A during IVF and another study indicated patients who choose to undergo PGT did so for reasons that were not evidence based. Additionally, educational materials have been illustrated to be inconsistent and with inappropriate literacy in regards to PGT counseling. One study has shown the potential of improvement with written intervention amongst providers and patients in regards to PGT related to a single genetic condition. The investigators hope to assess the efficacy of PGT-A educational and counseling interventions on patients undergoing IVF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Procedures: Patients undergoing IVF for the first time will be randomized to one of three groups

  1. Provider counseling (current standard care) with pre-test
  2. Handout on PGT-A and provider counseling (current standard care + educational intervention) with pre-test
  3. Handout on PGT-A, provider counseling and brief genetic counselor counseling (current standard of care + educational and counseling interventions) with pre-test

All patients will receive provider counseling(current standard of care) on PGT-A during their new IVF clinic visit. All groups will take a pre-test on PGT-A prior to receiving provider counseling and (if in an intervention group) prior to receiving handout or handout with brief counseling on PGT-A from a genetic counselor. At the end of their clinic visit, all participants will complete a post-test on PGT-A.

Two weeks after their clinic visit, all participants will receive a 2nd post-test on PGT-A and the SURE questionnaire to assess retained knowledge about PGT-A and decisional conflict about their choice to use PGT-A in their treatment cycle.

As there is not a validated knowledge survey for PGT-A, investigators have developed their own for pre- and post-tests. In order to validate the survey prior to using it in this study, investigators plan to enroll the first 100 participants in a pilot study to validate the instrument. The number needed for validation will depend on how much pilot participants scores vary between pre and post test. Participants in the pilot portion of the study will be asked to complete a pre-test on PGT-A, read the informational handout about PGT-A, and then complete a post test on PGT-A prior to their IVF appointment. Statisticians will analyze the pilot data as received, and will inform investigators when a sufficient number has been reached for survey validation. Once validated, the pilot arm of the study will be closed and will begin enrolling participants in the randomized trial portion described above.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52245
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing in vitro fertilization (IVF)

Exclusion Criteria:

  • Patients who have previously undergone IVF would be excluded.
  • Patients who have previously discussed PGT with a genetic counselor would be excluded.
  • Patients who do not speak English will be excluded.
  • Patients who are employees of the clinic would be excluded.
  • Patients who have an indication for PGT-M or PGT-SR would be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Provider counseling with pre-test
Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided.
Experimental: Handout on PGT-A and provider counseling with pre-test
Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided.
Other: Handout on PGT-A
Educational handout on PGT-A
Experimental: Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test
Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided.
Other: Handout on PGT-A
Educational handout on PGT-A
Other: Handout on PGT-A and genetic counseling
Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PGT-A Knowledge scores
Time Frame: Prior to new IVF visit
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Prior to new IVF visit
PGT-A Knowledge scores
Time Frame: Immediately following new IVF visit
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Immediately following new IVF visit
PGT-A Knowledge scores
Time Frame: Two weeks post IVF visit.
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Two weeks post IVF visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional conflict as measured by the SURE questionnaire.
Time Frame: Two weeks post IVF visit.
A validated questionnaire assessing patient decisional conflict on a scale of 0 to 4. Zero indicating no decisional conflict and 1 or greater indicating increasing levels of decisional conflict.
Two weeks post IVF visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyup Hakan Duran

Investigators

  • Study Director: Prapti Singh, DO, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

November 29, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202208644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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