Recruiting

Fertility Preservation

Sponsor:

Erin Rowell

Code:

NCT06692049

Conditions

DSD, 46,XY

DSD, Ovotesticular

DSD, Sex Chromosome

Disorders of Sex Development

Disorder of Sex Development, 46,XY

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Accepted

Interventions

Gonadectomy

Study Details

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.

Conditions

DSD, 46,XY

DSD, Ovotesticular

DSD, Sex Chromosome

Disorders of Sex Development

Disorder of Sex Development, 46,XY

Study ID

NCT06692049

Start date

Apr 4, 2018

Status verified date

Jul, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Gonadectomy

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

Primary outcome measure

  • Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sex Development [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Sara Reyes

3122274145FertilityPreservation@luriechildrens.org

Locations

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sara Reyes

312-227-4145FertilityPreservation@luriechildrens.org

Principal Investigator:

Erin Rowell, MD

More Information

Sponsor

Erin Rowell

Last update posted

Sep 3, 2026

Last verified

Jul, 2026

Keywords

  • DSD
  • GTC
  • Gonadectomy
  • Cryopreservation
  • Fertility Preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erin Rowell on 2026-09-03.