Fertility Decision-Making in Youth and Young Adults

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Transgender Adolescents & Young Adults

Treatments: Behavioral: Decision-aid

Study type: Interventional

Funder types: Other

Identifiers

NCT05175170

5R21HD097459

Details and patient eligibility

About

The aim of this study is to test if using a web-based medical decision-making tool on the topics of fertility and fertility-preservation increases knowledge among transgender youth and young adults.

Full description

The pilot trial of Aid for Fertility-Related Medical Decisions (AFFRMED) is a single-arm, pre-/post- feasibility, acceptability, and preliminary efficacy trial. 10 transgender adolescents and young adults (AYA) and 10 parents of transgender AYA participated in a 90-120 min, virtual research visit via Zoom. During this visit they completed pre-test measures of fertility knowledge and decisional self-efficacy, followed by up to 1 hour to freely navigate AFFRMED decision aid. After using AFFRMED, participants completed post-test measures of fertility knowledge and decisional self-efficacy, as well as implementation outcomes measures (Acceptability of Intervention, Intervention Appropriateness Measure, and Feasibility of Intervention Measure).

Enrollment: 20 patients

Sex: All

Ages: 8 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• (1) youth is between the ages of 8-14 years
• (2) youth self-asserts a transgender identity
• (3) youth has expressed interest in GnRHa or is currently on GnRHa treatment; or
• (1) AYA is between the ages of 13-24 years,
• (2) AYA self-asserts a transgender identity, and
• (3) AYA has expressed interest in gender-affirming hormone (GAH) or is currently on GAH treatment.
• Parents of eligible youth will be eligible to participate.

Exclusion criteria

• (1) youth/parents are unable to read, speak or understand English
• (2) youth/parents are unable or unwilling to provide consent/assent/parental permission for study participation.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Decision-aid

Experimental group

Description:

Participants will spend up to one hour freely navigating the web-based decision aid. They will complete pre- and post-test measures to determine if using the decision-aid website increased knowledge and impacted decision self-efficacy regarding fertility and fertility preservation.

Treatment:

Behavioral: Decision-aid