Freezing gonadal tissue to help preserve fertility in children with sex development disorders
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development
This study is testing whether freezing and storing gonadal tissue can help children with sex development disorders keep their fertility for the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06692049 on ClinicalTrials.gov |
What this trial studies
This study offers gonadal tissue freezing and storage for children diagnosed with disorders of sex development (DSD) who are at increased risk of infertility and certain cancers. It involves the removal of gonadal tissue for medical reasons, such as preventing cancer, followed by processing and long-term storage of the tissue. The goal is to potentially use this tissue in the future to help restore reproductive function. The study also aims to research long-term methods for preserving fertility in these children.
Who should consider this trial
Good fit: Ideal candidates include children under 30 diagnosed with a disorder of sex development who are at risk for malignancy in their gonadal tissue.
Not a fit: Patients who are pregnant or likely to retain inherent fertility and reproductive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help preserve the fertility potential of children with DSD who are at risk of infertility.
How similar studies have performed: While gonadal tissue cryopreservation is still considered experimental, similar approaches in fertility preservation have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individual \< 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 Exclusion Criteria: * Pregnant children * Patients likely to retain inherent fertility and reproductive function * Children deemed high risk for perioperative complications * Patients 12-18 unable to provide assent (i.e. significant psychiatric problems/cognitive delay) * Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Erin Rowell, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Sara Reyes
- Email: FertilityPreservation@luriechildrens.org
- Phone: 3122274145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.