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Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation
Sponsor: University of Colorado, Denver
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.
Key Details
Gender
All
Age Range
Any - 30 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2021-08-16
Completion Date
2031-06-30
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
Cryopreservation of gonadal tissue
Patients at risk for primary gonadal tumors will undergo unilateral or bilateral gonadectomy for clinical purposes as a standard of care, and a portion of the surgically removed tissue will be cryopreserved for fertility preservation. The pathologist will assess the tissue using sterile technique and every other section will undergo histologic analysis, including evaluation for the presence of tumor or viable germ cell elements. The sections of the tissue for fertility preservation will be refrigerated and held until a final diagnosis is made on the tissue sections that are being processed for histologic analysis. If no tumor is identified and viable germ cell elements are identified, the tissue sections allotted for preservation will be sent in holding media for processing and cryopreservation.
Locations (1)
University of Colorado
Aurora, Colorado, United States