Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation

NCT06518746 | Recruiting DMC

• 1 other identifier: 21-3159
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The "Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation" study is open to a subset of patients with disorders of sex development (DSD) which is associated with the risk of malignancy and a high risk of infertility or sterility. For these patients, experimental gonadal tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the safety and efficacy of gonadal tissue cryopreservation as a method of preserving fertility and/or restoring hormonal function in patients with gonadal dysgenesis who are at risk of decreased fertility potential or malignancy.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  Determine the efficacy of gonadal tissue and germ cells cryopreservation for patients' future use to restore fertility and/or hormone function. Efficacy is defined as at least 30% of patients having viable gonadal tissue and/or germ cells present.

  Up to 48 hours after obtaining gonadal tissue samples.

• Safety, as Assessed via the Proportion of adverse events

  Number and proportion of adverse events in gonadal tissue cryopreservation

  within 72 hours of gonadal tissue removal

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

  Descriptive analysis of survey responses, including the Decision Regret Scale scores (mean/median scores across domains).

  Through study completion, up to ten years.

• Level of demand

  Descriptive analysis of the proportion of eligible patients who elect gonadal tissue cryopreservation (numerator) out of those who are eligible (denominator).

  Through study completion, up to ten years.

Secondary Outcomes (2)

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

  Through study completion, up to ten years.

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

  Through study completion, up to ten years.

Study Arms (1)

Cryopreservation of gonadal tissue

EXPERIMENTAL

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

Other: Cryopreservation of gonadal tissue

Interventions

Cryopreservation of gonadal tissue OTHER

Patients at risk for primary gonadal tumors will undergo unilateral or bilateral gonadectomy for clinical purposes as a standard of care, and a portion of the surgically removed tissue will be cryopreserved for fertility preservation. The pathologist will assess the tissue using sterile technique and every other section will undergo histologic analysis, including evaluation for the presence of tumor or viable germ cell elements. The sections of the tissue for fertility preservation will be refrigerated and held until a final diagnosis is made on the tissue sections that are being processed for histologic analysis. If no tumor is identified and viable germ cell elements are identified, the tissue sections allotted for preservation will be sent in holding media for processing and cryopreservation.

Cryopreservation of gonadal tissue

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< 30 years of age
• 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
• Individuals diagnosed with a disorder of sex development who are at risk of primary ovarian insufficiency (POI) due to an underlying genetic condition

You may not qualify if:

• Pregnancy
• Patients likely to retain inherent fertility and reproductive function
• Patients deemed high risk for perioperative complications
• Patients 7-17 years of age 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Kristine Corkum, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristine Corkum, MD

CONTACT

(720) 777-6174; Kristine.Corkum@childrenscolorado.org

Jocelyn Phipers

CONTACT

303-724-7807; Jocelyn.Phipers@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 24, 2024
• Study Start: August 16, 2021
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)