Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation Study
This study is exploring a method called gonadal tissue cryopreservation (freezing and storing reproductive tissue) to help preserve fertility for individuals with certain disorders of sex development (DSD). These conditions can lead to a risk of cancer in the reproductive organs and/or infertility. For many, this experimental procedure is the only option to preserve their ability to have children. The study aims to see how well this method works (efficacy) and if it is safe. Researchers will look at how many tissue samples are viable and successfully frozen, and track any side effects. They will also ask patients and/or their guardians about their experience with this fertility preservation method.
- Study design
- This is an interventional study planning to enroll 50 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will undergo surgery to remove gonadal (reproductive) tissue as part of their standard medical care. A portion of this tissue will then be cryopreserved. Safety will be monitored for 72 hours after tissue removal, and acceptability will be assessed through surveys for up to ten years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety within 72 hours of tissue removal, and for acceptability through study completion, which could be up to ten years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kristine Corkum, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial 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.Up to 48 hours after obtaining gonadal tissue samples.
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.
- Safety, as Assessed via the Proportion of adverse eventswithin 72 hours of gonadal tissue removal
Number and proportion of adverse events in gonadal tissue cryopreservation
- Acceptability as a fertility preservation method, as Assessed via the survey responses by eligible patients and/or their guardians.Through study completion, up to ten years.
Descriptive analysis of survey responses, including the Decision Regret Scale scores (mean/median scores across domains).
- Level of demandThrough study completion, up to ten years.
Descriptive analysis of the proportion of eligible patients who elect gonadal tissue cryopreservation (numerator) out of those who are eligible (denominator).