NCT06692049

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Apr 2018Dec 2035

Study Start

First participant enrolled

April 4, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

12.8 years

First QC Date

August 28, 2020

Last Update Submit

November 14, 2024

Conditions

DSD, 46,XYDSD, OvotesticularDSD, Sex ChromosomeDisorders of Sex DevelopmentDisorder of Sex Development, 46,XYDisorder of Sex Development, 46,Xy, Cbx2-Related

Keywords

DSDGTCGonadectomyCryopreservationFertility Preservation

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of

    yearly, up to 20 years

Study Arms (1)

Disorders of Sex Development (DSD)

The 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, donated research tissue would be used to study long-term ways to preserve and restore reproductive function of children diagnosed with DSD

Procedure: Gonadectomy

Interventions

GonadectomyPROCEDURE

Gonadal tissue being removed for risk of malignancy may be cryopreserved for fertility preservation

Disorders of Sex Development (DSD)

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood specimens collected

MeSH Terms

Conditions

Disorder of Sex Development, 46,XYOvotesticular Disorders of Sex DevelopmentSex Chromosome Disorders of Sex DevelopmentDisorders of Sex Development46, XY Sex Reversal 5

Interventions

Castration

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesSex Chromosome DisordersChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical Procedures

Study Officials

  • Erin Rowell, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Reyes

CONTACT

3122274145FertilityPreservation@luriechildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Fertility & Hormone Preservation & Restoration

Study Record Dates

First Submitted

August 28, 2020

First Posted

November 18, 2024

Study Start

April 4, 2018

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations

US(1)