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NCT Number: NCT06692049

Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development

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.

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Key information

Conditions

DSD, 46,XY 46, XY Sex Reversal 5 Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DSD, Ovotesticular DSD, Sex Chromosome Disorder of Sex Development, 46,XY Disorder of Sex Development, 46,Xy, Cbx2-Related Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Male Urogenital Diseases Ovotesticular Disorders of Sex Development Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Urogenital Abnormalities Urogenital Diseases

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Erin Rowell, MD

CONTACT

Sara Reyes

CONTACT

[email protected]

312-227-4145

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gonadectomy

Procedure

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

Primary outcomes

  1. Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sex Development

    Time frame: 3 months

    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

  1. Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of

    Time frame: yearly, up to 20 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Reyes

CONTACT

[email protected]

3122274145

Sponsors and collaborators

Lead sponsor

Erin Rowell

Other

Collaborators

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

Registry information

Acronym: DSD

Important dates

Study start
2018
Primary completion
2030
Study completion
2035
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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