Clinical trial NCT06692049: Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development
Official title: Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DSD, 46,XY
DSD, Ovotesticular
DSD, Sex Chromosome
Disorders of Sex Development
Disorder of Sex Development, 46,XY
Disorder of Sex Development, 46,Xy, Cbx2-Related
Keywords: DSD
GTC
Gonadectomy
Cryopreservation
Fertility Preservation
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2024-11-18
Enrollment: 250
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: DSD are conditions in which there is incongruence in an individual's chromosomal, gonadal, or phenotypic sex (refers to sex as determined by an individual's internal or external genitalia and expression of secondary sex characteristics).Different DSD diagnoses have varying degrees of risk for future malignancy. The treating doctor has or will discuss with the participant the risk of developing cancer due to the child's specific diagnosis, and help decide whether this option is in the best interest of the child, and if there are other options to consider (e.g. leaving gonadal tissue in place and monitoring for development of malignancy). If the participant and family have decided to move forward with removal of gonadal tissue for this clinical reason, they will be asked if they would like to have the child participate in this study.

This study seeks to find out if removing gonadal tissue in adolescents and children at risk for losing fertility potential (the ability to have children) and who are scheduled to receive a gonadectomy (removal of gonads) for clinical purposes may preserve, or keep, their ability to have children in the future. Additionally, a primary objective of this study is to use donated research tissue to study long-term ways to preserve and restore reproductive function for children diagnosed with a DSD. Gonadal tissue cryopreservation in patients diagnosed with a DSD is still considered experimental. There have been no reported live births or pregnancies in this population following gonadal tissue cryopreservation at this time.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)

Primary outcomes:
measure: Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sex Development
timeFrame: 3 months
Secondary outcomes:
measure: Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of
timeFrame: yearly, up to 20 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Erin Rowell, MD
role: PRINCIPAL_INVESTIGATOR
References: