Actively Recruiting
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development
Led by Erin Rowell · Updated on 2024-11-18
250
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
E
Erin Rowell
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of gonadal tissue freezing and storage for children diagnosed with disorders of sex development (DSD), who face increased risks of infertility and certain cancers. The study aims to explore whether removing and preserving gonadal tissue during medically indicated gonadectomy can help maintain fertility potential in these children. Additionally, donated tissue will be used for research to find long-term methods of preserving and restoring reproductive function in DSD patients, a process still considered experimental with no reported live births so far. The study involves collecting gonadal tissue removed for clinical reasons, such as cancer prevention. This tissue will be processed and frozen for potential future use, then stored long-term until the child chooses to utilize it. The procedure occurs alongside the scheduled gonadectomy, with no additional invasive treatments introduced. The study primarily focuses on children and adolescents up to age 30 who require gonad removal due to their specific diagnosis. Participants will be followed to monitor the preservation process and fertility potential, with primary outcomes assessed three months after tissue cryopreservation. Long-term follow-up may continue yearly for up to 20 years to study ongoing preservation and reproductive function. The study includes assessments of tissue storage success and safety, with ongoing evaluation of participants' reproductive health and potential use of preserved tissue when desired.
CONDITIONS
Brief Title
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individual under 30 years of age
- Children diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue or will have their gonads removed for another clinical indication
You will not qualify if you...
- Pregnant children
- Patients likely to retain inherent fertility and reproductive function
- Children deemed high risk for perioperative complications
- Patients aged 12-18 unable to provide assent due to significant psychiatric problems or cognitive delay
- Patients 18 and older unable to provide consent due to significant psychiatric problems or cognitive delay
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 1 day to 1 week
Participants undergo gonadectomy to remove gonadal tissue for clinical reasons and fertility preservation.
1 surgical visit and several post-operative visits over the week
Duration - Up to 20 years
Participants are monitored yearly to study long-term fertility preservation and reproductive function after gonadal tissue cryopreservation.
Yearly visits for follow-up assessments
Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Sara Reyes
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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