An observational study in DSD, 46,XY, DSD, Ovotesticular and DSD, Sex Chromosome, sponsored by Erin Rowell. Recruiting at 1 site in United States. Open to participants aged Up to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Erin Rowell · Observational
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.
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.
32 studies on the registry are indexed under Disorders of Sex Development; 7 are open to participants now.
This study's planned enrollment of 250 is above the median of 84 across 17 observational studies indexed under Disorders of Sex Development.
Browse Disorders of Sex Development studies →Erin Rowell is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Started Apr 2018 (actual). Primary completion is estimated for Dec 2030, 152 months after the start.
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Disorders of Sex Development →
Erin Rowell