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

November 14, 2024 updated by: Erin Rowell
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Gonadal tissue being removed for risk of malignancy may be cryopreserved for fertility preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
yearly, up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erin Rowell

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Erin Rowell, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2018

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1164

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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