250 Participants Needed

Gonadal Tissue Cryopreservation for Disorder of Sex Development

(DSD Trial)

SR
Overseen BySara Reyes
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Erin Rowell
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children with a disorder of sex development (DSD) preserve their future ability to have children. It involves freezing and storing gonadal tissue removed to prevent cancer. The goal is to potentially use this tissue later for reproductive purposes. Children who might be suitable candidates have DSD and face infertility risk due to the necessary removal of their gonads. As an unphased trial, this study offers a unique opportunity for children to potentially preserve their future fertility.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that gonadal tissue cryopreservation is safe for children with disorders of sex development?

Research has shown that freezing and storing reproductive tissue, known as gonadal tissue cryopreservation, is generally well-tolerated. This method is under study for children with disorders of sex development (DSD) who might face future infertility. Studies have found that many families opt for this procedure before necessary surgery to remove the gonads, aiming to preserve future fertility.

No major reports of problems linked to the freezing process itself have emerged, indicating that the procedure does not cause significant harm or discomfort. While researchers continue to study the long-term effects, early results about using the frozen tissue for births are promising. However, scientists are thoroughly exploring its safety and effectiveness.

In summary, gonadal tissue cryopreservation appears to be a safe option for preserving fertility in children with DSD, with no significant safety concerns reported so far.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a potentially groundbreaking approach for preserving fertility in children with Disorders of Sex Development (DSD). Unlike current options that might not prioritize future fertility during necessary surgeries, this method involves cryopreserving gonadal tissue before a gonadectomy. The unique aspect here is the dual focus: not only could this preserve the ability to have children in the future, but studying the donated tissue might also lead to new ways to restore reproductive function long-term. This could open new doors in fertility preservation, offering hope to those at risk of losing this vital aspect of their future.

What evidence suggests that gonadal tissue cryopreservation might be an effective treatment for preserving fertility in children with DSD?

Research has shown that freezing gonadal tissue can help preserve fertility in children with sex development disorders (DSD). Studies have found that the gonads in people with DSD often contain germ cells, which are crucial for future reproduction. In this trial, participants scheduled for a gonadectomy for clinical reasons may choose to freeze this tissue, hoping to retain the option of having children later. Although the use of frozen gonadal tissue is still under study, early findings are promising, particularly for children requiring treatments that might impact their fertility. This method offers a chance to preserve tissue that could aid in future reproduction.12356

Who Is on the Research Team?

ER

Erin Rowell, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

I am under 30 years old.
My child has a sex development disorder with a risk of cancer in their gonads or needs gonad removal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gonadectomy and Tissue Cryopreservation

Participants undergo gonadectomy for clinical purposes and gonadal tissue is processed and cryopreserved for potential future use

1 week
1 visit (in-person)

Follow-up

Participants are monitored for development of secondary sex characteristics, puberty progression, and potential future fertility

yearly, up to 20 years

What Are the Treatments Tested in This Trial?

Interventions

  • Gonadal Tissue Cryopreservation

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Disorders of Sex Development (DSD)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Erin Rowell

Lead Sponsor

Trials
4
Recruited
850+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials
275
Recruited
5,182,000+

Citations

Gonadal Tissue Cryopreservation for Fertility Preservation ...

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) ...

Differences in gonadal tissue cryopreservation practices for ...

Gonads of individuals with DSD can contain germ cells and precursors and patients interested in future fertility preservation and hormonal restoration can ...

Decision-making experiences in gonadectomy and ...

57% (4/7) of AYA and 72% (8/11) of parent participants self-reported a decision to cryopreserve gonadal tissue prior to gonadectomy. We ...

Gonadal Tissue Cryopreservation for Children with ...

Although recent studies regarding birth outcomes with cryopreserved gonadal tissue are encouraging [11, 12, 17, 18], it is currently unknown ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31509845/

Gonadal Tissue Cryopreservation for Children with ...

Gonadal tissue cryopreservation (GTC) for fertility preservation (FP) is offered to children with cancer undergoing gonadotoxic therapy.

Gonadal Dysgenesis Tissue Cryopreservation for Fertility ...

Thus, the investigators are conducting a pilot study to assess the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility ...