Trial Outcomes & Findings for Fertility Decision-Making in Youth and Young Adults (NCT NCT05175170)
NCT ID: NCT05175170
Last Updated: 2023-04-07
Results Overview
The primary study outcome is change in fertility-related knowledge from same-day pre-AFFRMED to post-AFFRMED exposure. Participants will complete a fertility-related knowledge test instrument immediately prior to AFFRMED exposure. Participants will be given 1 hour to freely navigate the web-based AFFRMED prototype. Thereafter, participants will get a 5-minute break before completing a post-AFFRMED fertility knowledge test. The knowledge test consists of 41 items, and reflects a percentage correct score ranging from 0-100% correct. The Mean Difference results reflect the difference in fertility knowledge test mean scores between pre-AFFRMED and post-AFFRMED exposure.
COMPLETED
NA
20 participants
Pre-treatment and immediately post-treatment (same day)
2023-04-07
Participant Flow
Participant milestones
| Measure |
Transgender Youth and Young Adults
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fertility Decision-Making in Youth and Young Adults
Baseline characteristics by cohort
| Measure |
Transgender Youth and Young Adults
n=10 Participants
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
n=10 Participants
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 3.779 • n=99 Participants
|
45.00 years
STANDARD_DEVIATION 4.83 • n=107 Participants
|
30.25 years
STANDARD_DEVIATION 15.711 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment and immediately post-treatment (same day)The primary study outcome is change in fertility-related knowledge from same-day pre-AFFRMED to post-AFFRMED exposure. Participants will complete a fertility-related knowledge test instrument immediately prior to AFFRMED exposure. Participants will be given 1 hour to freely navigate the web-based AFFRMED prototype. Thereafter, participants will get a 5-minute break before completing a post-AFFRMED fertility knowledge test. The knowledge test consists of 41 items, and reflects a percentage correct score ranging from 0-100% correct. The Mean Difference results reflect the difference in fertility knowledge test mean scores between pre-AFFRMED and post-AFFRMED exposure.
Outcome measures
| Measure |
Transgender Youth and Young Adults
n=10 Participants
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
n=10 Participants
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
|---|---|---|
|
Change in Fertility-related Knowledge
Pre-test Score
|
51.463 score on a scale
Standard Deviation 21.585
|
67.073 score on a scale
Standard Deviation 6.729
|
|
Change in Fertility-related Knowledge
Post-test Score
|
85.366 score on a scale
Standard Deviation 14.858
|
93.171 score on a scale
Standard Deviation 2.998
|
SECONDARY outcome
Timeframe: Pre-treatment and immediately post-treatment (same day)The secondary study outcome is change in decisional self-efficacy for fertility-related decision-making from same-day pre-AFFRMED to post-AFFRMED exposure using the Decision Self Efficacy Scale. Decision Self Efficacy Scale scores range from 0 \[not at all confident\] to 100 \[very confident\]. A score of 0 indicates 'extremely low self-efficacy' and a score of 100 indicates 'extremely high self-efficacy'. The Mean Difference results reflect the difference in decisional self-efficacy mean scores between pre-AFFRMED and post-AFFRMED exposure.
Outcome measures
| Measure |
Transgender Youth and Young Adults
n=10 Participants
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
n=10 Participants
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
|---|---|---|
|
Change in Decisional Self-Efficacy
Pre-test Score
|
61.364 score on a scale
Standard Deviation 17.309
|
83.864 score on a scale
Standard Deviation 15.653
|
|
Change in Decisional Self-Efficacy
Post-test Score
|
80.303 score on a scale
Standard Deviation 14.903
|
92.929 score on a scale
Standard Deviation 9.739
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-treatment (same day)The other study outcomes are related to participant-reported feasibility of the AFFRMED. Participants will also be asked to rate the feasibility of the AFFRMED using the validated Feasibility of Intervention Measure (FIM). Scale scores range from 4 to 20, with higher scores indicating greater feasibility.
Outcome measures
| Measure |
Transgender Youth and Young Adults
n=10 Participants
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
n=10 Participants
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
|---|---|---|
|
Participant-Reported Feasibility of AFFRMED
|
17.50 score on a scale
Standard Deviation 3.308
|
18.60 score on a scale
Standard Deviation 2.366
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-treatment (same day)The other study outcomes are related to participant-reported acceptability of the AFFRMED. Participants will also be asked to rate the acceptability of the AFFRMED using the validated Acceptability of Intervention Measure (AIM). Scale scores range from 4 to 20, with higher scores indicating greater acceptability.
Outcome measures
| Measure |
Transgender Youth and Young Adults
n=10 Participants
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
n=10 Participants
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
|---|---|---|
|
Participant-Reported Acceptability of AFFRMED
|
16.70 score on a scale
Standard Deviation 4.244
|
18.90 score on a scale
Standard Deviation 1.853
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-treatment (same day)The other study outcomes are related to participant-reported appropriateness of the AFFRMED. Participants will also be asked to rate the appropriateness of the AFFRMED using the validated Intervention Appropriateness Measure (IAM). Scale scores range from 4 to 20, with higher scores indicating greater appropriateness.
Outcome measures
| Measure |
Transgender Youth and Young Adults
n=10 Participants
Transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
Parents of Transgender Youth and Young Adults
n=10 Participants
Parents of transgender youth and young adults will navigate the decision-aid consisting of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
|
|---|---|---|
|
Participant-Reported Appropriateness of AFFRMED
|
17.30 score on a scale
Standard Deviation 3.917
|
18.20 score on a scale
Standard Deviation 3.011
|
Adverse Events
Transgender Youth and Young Adults
Parents of Transgender Youth and Young Adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Diane Chen
Ann & Robert H. Lurie Children's Hospital of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place