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 histologic evaluation of the gonads for the presence of germ cells which will be cryopreserved for potential future fertility.
Secondary outcomes
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of
Secondary outcomes include long term follow up of study participants for development of secondary sex characteristics, puberty progression, and ability for the participant to have their own children as adults if desired.
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