Preimplantation Genetic Testing for Aneuploidy Counseling

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patient Education

Intervention / Treatment
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* Other: Handout on PGT-A
* Other: Handout on PGT-A and genetic counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGT-A Knowledge scores | 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 | 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 | 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. | 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. |