Preimplantation Genetic Testing for Aneuploidy Counseling

Patient Education Clinical Trial

— PGT-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018454
• Other study ID #: 202208644
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: University of Iowa
• Contact: Hakan Duran, MD
• Phone: 319-356-4645
• Email: hakan-duran[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneuploidy
• Patient Education

Intervention

Other:
• Handout on PGT-A
Educational handout on PGT-A
• Handout on PGT-A and genetic counseling
Handout on PGT-A and genetic counseling session with a genetic counselor on PGT-A

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eyup Hakan Duran

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.