Recruiting

Fertility Preservation

Sponsor:

University of Colorado, Denver

Code:

NCT06518746

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Cryopreservation of gonadal tissue

Study Details

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

Study ID

NCT06518746

Start date

Aug 16, 2021

Status verified date

Sep, 2025

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • < 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cryopreservation of gonadal tissue

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

Interventions

Cryopreservation of gonadal tissue

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.

Primary outcome measure

  • 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. [ Time Frame: Up to 48 hours after obtaining gonadal tissue samples. ]
  • Safety, as Assessed via the Proportion of adverse events [ Time Frame: 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. [ Time Frame: Through study completion, up to ten years. ]
  • Level of demand [ Time Frame: Through study completion, up to ten years. ]

Central Contacts and Locations

Central contacts

Kristine Corkum, MD

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

Jocelyn Phipers

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

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Corkum Kristine, MD

Kristine.Corkum@childrenscolorado.org

Jocelyn Phipers, RN

303-724-7807jocelyn.phipers@cuanschutz.edu

Principal Investigator:

Kristine Corkum, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-18.