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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 30
SponsorErin Rowell

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Gonadectomy

    Procedure/Surgery

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

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Disorders of Sex Development (DSD)1 intervention

Trial outcomes

Primary outcomes

1

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

The primary outcome is to evaluate the presence of viable germs cells based on histologic evaluation of the gonads for number of germ cells per high power field and to cryopreserve the tissue.

Time frame
3 months

Secondary outcomes

1

Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sexual Development (DSD)

Secondary outcomes: 1\. Utilize donated research tissue biopsy to establish and investigate technologies that will enable long-term preservation of reproductive function in patients with DSD. In particular the tissue will be used to optimize techniques for freezing and thawing of gonadal tissue for use in tissue transplant, in-vitro follicle maturation, or obtaining spermatogonial stem cells.

Time frame
yearly, up to 20 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erin Rowell

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Sponsor institution

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator