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RECRUITINGINTERVENTIONAL

Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - \< 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

OTHER

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