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Fertility Preservation Discussion for Cancer

N/A
Waitlist Available
Led By Leena Nahata, MD
Research Sponsored by Leena Nahata
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male
Aged 12-25 years
Must not have
Cognitive deficit that precludes completing measures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether having a guided conversation about fertility preservation with an expert increases the rates of fertility preservation and/or satisfaction with the decision among adolescent and young adult males with cancer.

Who is the study for?
This trial is for young males aged 12-25 with a new cancer diagnosis who are about to start treatment that could affect fertility. They must understand English and be at a certain stage of puberty to bank sperm. It's not for those with cognitive issues or non-English speaking parents.
What is being tested?
The study tests if a special tool and conversation about sperm banking before cancer treatment can help increase the number of young men preserving their fertility and improve satisfaction with their decision, compared to just getting routine fertility advice.
What are the potential side effects?
Since this trial involves discussions rather than medical treatments, there are no direct physical side effects. However, participants may experience emotional or psychological impacts from conversations about fertility preservation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am male.
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I am between 12 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have difficulty with thinking or memory that makes it hard for me to complete tasks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fertility Preservation (FP) Uptake
Secondary study objectives
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FP Decision Tool and Discussion (Treatment)Experimental Treatment1 Intervention
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
Group II: Standard of Care (Control)Active Control1 Intervention
Participants will receive a standard of care fertility consult.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,961 Total Patients Enrolled
Leena NahataLead Sponsor
Leena Nahata, MDPrincipal InvestigatorNationwide Children's Hospital

Media Library

FP Decision Tool and Discussion Clinical Trial Eligibility Overview. Trial Name: NCT04268004 — N/A
Male Infertility Research Study Groups: Standard of Care (Control), FP Decision Tool and Discussion (Treatment)
Male Infertility Clinical Trial 2023: FP Decision Tool and Discussion Highlights & Side Effects. Trial Name: NCT04268004 — N/A
FP Decision Tool and Discussion 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268004 — N/A
~8 spots leftby Nov 2025