NCT06018454: PGT-A

Preimplantation Genetic Testing for Aneuploidy Counseling

Completed NA Last updated 24 December 2024

What this trial tests

NA trial testing Handout on PGT-A in Patient Education in 213 participants. Completed in 29 November 2024.

Timeline

20 December 2022

Primary endpoint
30 October 2024

29 November 2024

Quick facts

Lead sponsor	Eyup Hakan Duran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	213
Start date	20 December 2022
Primary completion	30 October 2024
Estimated completion	29 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Handout on PGT-A
• Handout on PGT-A and genetic counseling

Conditions studied

• Patient Education — all drugs for Patient Education →

Sponsor

Eyup Hakan Duran

Who can join

Adults 18 to 45, any sex, with Patient Education. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized controlled trial of counseling and educational methods on preimplantation genetic testing for aneuploidy for patients pursuing in vitro fertilization.
   Singh P, Summers KM, Chanouha N, Thoeny R, et al · · 2025 · PMID 40523553 · DOI 10.1016/j.fertnstert.2025.06.010