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Recruiting NCT06692049

NCT06692049 Gonadal Tissue Cryopreservation for Fertility Preservation in Children with a Disorder of Sex Development

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Clinical Trial Summary
NCT ID NCT06692049
Status Recruiting
Phase
Sponsor Erin Rowell
Condition DSD, 46,XY
Study Type OBSERVATIONAL
Enrollment 250 participants
Start Date 2018-04-04
Primary Completion 2030-12-31

Trial Parameters

Condition DSD, 46,XY
Sponsor Erin Rowell
Study Type OBSERVATIONAL
Phase N/A
Enrollment 250
Sex ALL
Min Age N/A
Max Age 30 Years
Start Date 2018-04-04
Completion 2030-12-31
Interventions
Gonadectomy

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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.

Eligibility Criteria

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)

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