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Preimplantation Genetic Testing for Aneuploidy Counseling (PGT-A)

Primary Purpose

Patient Education

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Handout on PGT-A
Handout on PGT-A and genetic counseling
Sponsored by
Eyup Hakan Duran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patient Education

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Provider counseling with pre-test

Handout on PGT-A and provider counseling with pre-test

Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test

Arm Description

Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided.

Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided.

Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided.

Outcomes

Primary Outcome Measures

PGT-A Knowledge scores
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
PGT-A Knowledge scores
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
PGT-A Knowledge scores
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.

Secondary Outcome Measures

Decisional conflict as measured by the SURE questionnaire.
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.

Full Information

First Posted
August 1, 2023
Last Updated
August 28, 2023
Sponsor
Eyup Hakan Duran
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1. Study Identification

Unique Protocol Identification Number
NCT06018454
Brief Title
Preimplantation Genetic Testing for Aneuploidy Counseling
Acronym
PGT-A
Official Title
Preimplantation Genetic Testing for Aneuploidy (PGT-A) Counseling for Patients Undergoing in Vitro Fertilization (IVF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eyup Hakan Duran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
Procedures: Patients undergoing IVF for the first time will be randomized to one of three groups Provider counseling (current standard care) with pre-test Handout on PGT-A and provider counseling (current standard care + educational intervention) with pre-test 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized with computer generated block randomization of ratio 1:1:1 to randomize women to either 10 minute genetic counseling intervention with handout, handout, or no interventions. Randomization allocation will be performed prior to study initiation through the Institute for Clinical and Translational Science (ICTS) via REDCap software.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Provider counseling with pre-test
Arm Type
No Intervention
Arm Description
Counseling regarding PGT-A only with a provider(current standard of care), pre-test provided.
Arm Title
Handout on PGT-A and provider counseling with pre-test
Arm Type
Experimental
Arm Description
Counseling regarding PGT-A with a provider and review of a handout(educational intervention), pre-test provided.
Arm Title
Handout on PGT-A, provider counseling and brief genetic counselor counseling with pre-test
Arm Type
Experimental
Arm Description
Counseling regarding PGT-A only with a provider, review of a handout(educational intervention) and genetic counseling (counseling intervention), pre-test provided.
Intervention Type
Other
Intervention Name(s)
Handout on PGT-A
Intervention Description
Educational handout on PGT-A
Intervention Type
Other
Intervention Name(s)
Handout on PGT-A and genetic counseling
Intervention Description
Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A
Primary Outcome Measure Information:
Title
PGT-A Knowledge scores
Description
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Time Frame
Prior to new IVF visit
Title
PGT-A Knowledge scores
Description
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Time Frame
Immediately following new IVF visit
Title
PGT-A Knowledge scores
Description
Study team designed 7 item knowledge questionnaire. Lowest score being 0 and highest score being 7.
Time Frame
Two weeks post IVF visit.
Secondary Outcome Measure Information:
Title
Decisional conflict as measured by the SURE questionnaire.
Description
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.
Time Frame
Two weeks post IVF visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Duran, MD
Phone
319-356-4645
Email
hakan-duran@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Summers, MPH
Phone
319-356-8862
Email
karen-summers@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prapti Singh, DO
Organizational Affiliation
University of Iowa
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prapti Singh
Phone
202-679-1983
Email
prapsingh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26474735
Citation
Gebhart MB, Hines RS, Penman A, Holland AC. How do patient perceived determinants influence the decision-making process to accept or decline preimplantation genetic screening? Fertil Steril. 2016 Jan;105(1):188-93. doi: 10.1016/j.fertnstert.2015.09.022. Epub 2015 Oct 24.
Results Reference
background
PubMed Identifier
33040985
Citation
Lee I, Alur-Gupta S, Gallop R, Dokras A. Utilization of preimplantation genetic testing for monogenic disorders. Fertil Steril. 2020 Oct;114(4):854-860. doi: 10.1016/j.fertnstert.2020.05.045.
Results Reference
background
PubMed Identifier
32756971
Citation
Kaing A, Rosen MP, Quinn MM. Perceptions, motivations and decision regret surrounding preimplantation genetic testing for aneuploidy. Hum Reprod. 2020 Sep 1;35(9):2047-2057. doi: 10.1093/humrep/deaa154.
Results Reference
background
PubMed Identifier
30334131
Citation
Quinn MM, Juarez-Hernandez F, Dunn M, Okamura RJ, Cedars MI, Rosen MP. Decision-making surrounding the use of preimplantation genetic testing for aneuploidy reveals misunderstanding regarding its benefit. J Assist Reprod Genet. 2018 Dec;35(12):2155-2159. doi: 10.1007/s10815-018-1337-8. Epub 2018 Oct 18.
Results Reference
background
PubMed Identifier
19652605
Citation
McGowan ML, Burant CJ, Moran R, Farrell R. Patient education and informed consent for preimplantation genetic diagnosis: health literacy for genetics and assisted reproductive technology. Genet Med. 2009 Sep;11(9):640-5. doi: 10.1097/GIM.0b013e3181ac6b52.
Results Reference
background
PubMed Identifier
32472448
Citation
Early ML, Kumar P, Marcell AV, Lawson C, Christianson M, Pecker LH. Literacy assessment of preimplantation genetic patient education materials exceed national reading levels. J Assist Reprod Genet. 2020 Aug;37(8):1913-1922. doi: 10.1007/s10815-020-01837-z. Epub 2020 May 29.
Results Reference
background
PubMed Identifier
34806131
Citation
Early ML, Strodel RJ, Lake IV, Ruddy JA, Saba JA, Singh SM, Lanzkron S, Mack JW, Meier ER, Christianson MS, Pecker LH. Acceptable, hopeful, and useful: development and mixed-method evaluation of an educational tool about reproductive options for people with sickle cell disease or trait. J Assist Reprod Genet. 2022 Jan;39(1):183-193. doi: 10.1007/s10815-021-02358-z. Epub 2021 Nov 22.
Results Reference
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Preimplantation Genetic Testing for Aneuploidy Counseling

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