Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation
NCT Number: NCT06518746
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ovarian Cancer
Interventions: OTHER: Cryopreservation of gonadal tissue
Sponsor: University of Colorado, Denver
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-08-16
Completion Date: 2031-06-30
Locations: University of Colorado, Aurora, Colorado, 80045, United States

Summary:
The "Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation" study is open to a subset of patients with disorders of sex development (DSD) which is associated with the risk of malignancy and a high risk of infertility or sterility. For these patients, experimental gonadal tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility and/or restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy.

Primary Outcome Measures: Efficacy, as Assessed via the Proportion of total samples containing viable gonadal tissue and/or the presence of germ cells, and the Proportion of total samples that were successfully cryopreserved for the patient's future use., Determine the efficacy of gonadal tissue and germ cells cryopreservation for patients' future use to restore fertility and/or hormone function. Efficacy is defined as at least 30% of patients having viable gonadal tissue and/or germ cells present., Up to 48 hours after obtaining gonadal tissue samples.|Safety, as Assessed via the Proportion of adverse events, Number and proportion of adverse events in gonadal tissue cryopreservation, within 72 hours of gonadal tissue removal|Acceptability as a fertility preservation method, as Assessed via the survey responses by eligible patients and/or their guardians., Descriptive analysis of survey responses, including the Decision Regret Scale scores (mean/median scores across domains)., Through study completion, up to ten years.|Level of demand, Descriptive analysis of the proportion of eligible patients who elect gonadal tissue cryopreservation (numerator) out of those who are eligible (denominator)., Through study completion, up to ten years.
Secondary Outcome Measures: Create a recruitment database of patients/caregivers that consent to future contact to consider participating in other research studies pertaining to fertility preservation., Descriptive analysis of the proportion of patients providing additional consent for future, Through study completion, up to ten years.|Determine if there are disparities in the type of patients consenting to future contact for research studies pertaining to fertility preservation, Descriptive analysis of the type of patients (including but not limited to age, race, ethnicity, insurance type, medical history/diagnosis) who elect to be contacted for future research opportunities. A Pearson Chi-squared test can be used to examine if this proportion varies across groups. A 2-sample t-test can be used to compare age (continuous) between those who consent to future research and those who did not., Through study completion, up to ten years.