N/A
N=52
Fertility Preservation in Male AYA With Cancer
Infertility, Male
Bottom Line
View on ClinicalTrials.gov: NCT04268004 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Fertility Preservation (FP) Uptake — 10; 9 Participants — p==.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FP Decision Tool and Discussion (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Male
- Sponsor
- Leena Nahata
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fertility Preservation (FP) Uptake |
10; 9 | =.64 |
| SECONDARY Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA |
1.7; 1.1; 5.7; 6.0; 6.1; 6.3 | — |
| SECONDARY Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver |
1.8; 1.4; 5.4; 5.9; 6.5; 7.0 | — |
| SECONDARY Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA |
1.7; 1.1; 5.7; 6.0; 6.1; 6.3 | — |
| SECONDARY Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver |
1.8; 1.4; 5.4; 5.9; 6.5; 7.0 | — |
Summary
Very little is known about how medical providers can help adolescent and young adults (AYAs) and their caregivers make decisions about fertility preservation (sperm banking) before beginning cancer treatment. The purpose of this study is to see if having a guided conversation about fertility preservation increases preservation rates and/or satisfaction with the decision among AYA males with cancer. The primary hypothesis is that compared to standard of care control group (routine fertility consult at diagnosis, n=20), AYAs in the intervention arm (routine fertility consult at diagnosis + FP Decision Tool and Facilitated Conversation by trained interventionist) will have higher rates of FP uptake. The secondary hypothesis is that families in the intervention group will report better FP decision quality compared to those in the control arm.
Eligibility Criteria
Inclusion Criteria
- Male
- Aged 12-25 years
- Expected to have adjuvant therapy (chemotherapy and/or gonadal radiation) for newly diagnosed cancer
- Pubertal (at least Tanner stage 2-3, eligible for sperm banking as determined in the fertility consult)
- Proficient in English
Exclusion Criteria
- Cognitive deficit that precludes completing measures
- Parents are non-English speaking
Data sourced from ClinicalTrials.gov (NCT04268004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.