About this trial
The purpose of this study is to offer gonadal tissue freezing and storage to children who are diagnosed with a disorder of sex development (DSD), who are at increased risk of infertility and certain malignancies (cancer). This study involves the storage of gonadal tissue that is being removed for medical reasons (e.g. prevention of cancer development). It includes the processing and freezing of this gonadal tissue, hopefully for potential future use. The tissue will then be stored long-term until the child wishes to try to use the tissue.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individual < 30 years of age
Children diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue or will have their gonads removed for another clinical indication
Disqualifiers
Pregnant children
Patients likely to retain inherent fertility and reproductive function
Children deemed high risk for perioperative complications
Patients 12-18 unable to provide assent (i.e. significant psychiatric problems/cognitive delay)
Trial population
Children diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue or will have their gonads removed for another clinical indication
Trial design
Cohort
Prospective
Treatments tested in this trial
Gonadectomy
Procedure/SurgeryGonadal tissue being removed for risk of malignancy may be cryopreserved for fertility preservation
Treatment groups
Trial outcomes
Primary outcomes
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sex Development
The primary outcome is to evaluate the presence of viable germs cells based on histologic evaluation of the gonads for number of germ cells per high power field and to cryopreserve the tissue.
Secondary outcomes
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sexual Development (DSD)
Secondary outcomes: 1\. Utilize donated research tissue biopsy to establish and investigate technologies that will enable long-term preservation of reproductive function in patients with DSD. In particular the tissue will be used to optimize techniques for freezing and thawing of gonadal tissue for use in tissue transplant, in-vitro follicle maturation, or obtaining spermatogonial stem cells.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erin Rowell
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborator