A randomized controlled trial of counseling and educational methods on preimplantation genetic testing for aneuploidy for patients pursuing in vitro fertilization.

OBJECTIVE

To prospectively compare methods of education and counseling on preimplantation genetic testing for aneuploidy.

DESIGN

Randomized controlled trial.

SUBJECTS: Single and partnered patients undergoing their first in vitro fertilization treatment cycle who were able to understand and communicate in English and had not been counseled previously on preimplantation genetic testing for aneuploidy.

INTERVENTION: Patients were randomized in a 1:1:1 ratio to one of three groups: reproductive endocrinology and infertility (REI) provider counseling only (reference group), REI provider counseling and a handout, or REI provider counseling, a handout, and a brief genetic counseling intervention.

MAIN OUTCOME MEASURES: The primary outcome was knowledge scores postvisit (%). Secondary outcomes were knowledge scores 2 weeks postvisit (%), decisional conflict, and decisional regret.

RESULTS

A total of 105 patients (a) and 97 partners (b) enrolled. The patient's and partner's mean age (±SD) was 32.2 (4.2) and 33.9 (5.2) years, respectively. Patient and partner knowledge scores were higher with a handout (a-79.4% [72.9-86.0]; b-62.4% [55.0-69.8]) and a handout with a brief genetic counseling intervention (a-80.8% [74.1-87.6]; b-73.4% [65.1-81.7]) compared with REI provider-only counseling (a-46.9% [40.5-53.4]; b-43.0% [35.3-50.6]) at the postvisit survey. At 2 weeks postvisit, patient knowledge scores were higher with the handout (75.9% [69.1-82.8]) and a handout with brief genetic counseling intervention (79.6% [71.7-87.4]) compared with REI provider-only counseling (49.9% [43.4-56.4]), and for partners in the handout with brief genetic counseling intervention group (72.6% [61.7-83.4]) compared with REI provider-only counseling (46.9% [37.8-56.0]). We did not observe a difference in decisional conflict or regret, yet we were powered to only detect an absolute difference of 35% between groups with 82% power for decisional conflict and a difference of 8 points (10) with 85% power in mean decisional regret scores.

CONCLUSION

Patient and partner knowledge improved with educational handouts and brief genetic counseling interventions.

CLINICAL TRIAL REGISTRATION NUMBER: NCT06018454-https://clinicaltrials.gov/study/NCT06018454?term=NCT06018454&rank=1.