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Gonadal Tissue Cryopreservation for Fertility Preservation

N/A

Recruiting

Led By Leslie Appiah, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue and will have their gonads removed for a clinical indication

< 30 years of age

Must not have

Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)

Patients 7-17 years of age unable to provide assent (i.e. significant psychiatric problems/cognitive delay)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to ten years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate a method called gonadal tissue cryopreservation for preserving fertility in patients with certain disorders. These disorders can increase the risk of cancer and infertility. The study will assess how safe

Who is the study for?

This trial is for patients with disorders like Turner Syndrome, who face a high risk of infertility or ovarian cancer. It's open to those who have limited fertility preservation options due to their condition.

What is being tested?

The study tests the safety and effectiveness of freezing gonadal tissue (ovaries) to preserve fertility and possibly restore hormone function in patients at risk of infertility or cancer.

What are the potential side effects?

Potential side effects are not detailed here but may include complications from surgical procedures required for tissue removal and risks associated with cryopreservation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am diagnosed with a sex development disorder and need my gonads removed due to cancer risk.

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I am under 30 years old.

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I have a genetic condition putting me at risk of early ovarian failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am over 18 and capable of giving my own consent.

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My child is between 7-17 years old and cannot give consent due to mental health or cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to ten years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to ten years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to ten years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability as a fertility preservation method, as Assessed via the survey responses by eligible patients and/or their guardians.

Efficacy, as Assessed via the Proportion of total samples containing viable gonadal tissue and/or the presence of germ cells, and the Proportion of total samples that were successfully cryopreserved for the patient's future use.

Level of demand

+1 more

Secondary study objectives

Create a recruitment database of patients/caregivers that consent to future contact to consider participating in other research studies pertaining to fertility preservation.

Determine if there are disparities in the type of patients consenting to future contact for research studies pertaining to fertility preservation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cryopreservation of gonadal tissueExperimental Treatment1 Intervention

Enrolled participants will undergo gonadal tissue processing, freezing and cryopreservation after the standard care (gonadectomy, gonadal tissue histologic examination)

0 / 5Eligibility criteria met