Cryopreservation of gonadal tissue for fertility preservation in patients with disorders of sex development
Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation
This study is testing if freezing gonadal tissue can help young people with disorders of sex development preserve their fertility and hormonal health before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06518746 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with disorders of sex development (DSD) who are at risk of infertility or malignancy due to abnormal gonadal development. It aims to assess the safety and efficacy of gonadal tissue cryopreservation as a method for preserving fertility and restoring hormonal function. Participants under 30 years of age who require gonadectomy for clinical reasons will be included, while those with inherent fertility or significant cognitive issues will be excluded. The study seeks to provide a viable fertility preservation option for this unique patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals under 30 years of age diagnosed with a disorder of sex development who are at risk for malignancy in their gonadal tissue.
Not a fit: Patients who are likely to retain inherent fertility and reproductive function or those with significant cognitive delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a critical fertility preservation option for individuals with disorders of sex development at risk of infertility.
How similar studies have performed: While this approach is novel for the specific population of patients with DSD, similar cryopreservation techniques have shown promise in other fertility preservation contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \< 30 years of age * Individuals diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue and will have their gonads removed for a clinical indication * Individuals diagnosed with a disorder of sex development who are at risk of primary ovarian insufficiency (POI) due to an underlying genetic condition Exclusion Criteria: * Pregnancy * Patients likely to retain inherent fertility and reproductive function * Patients deemed high risk for perioperative complications * Patients 7-17 years of age 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
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Kristine Corkum, MD — University of Colorado, Denver
- Study coordinator: Kristine Corkum, MD
- Email: Kristine.Corkum@childrenscolorado.org
- Phone: (720) 777-6174
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.