RECRUITING

Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gonadal Dysgenesis Tissue Cryopreservation for Fertility Preservation

Quick Facts

Study Start:2021-08-16
Study Completion:2031-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06518746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * \< 30 years of age
  2. * 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
  3. * Individuals diagnosed with a disorder of sex development who are at risk of primary ovarian insufficiency (POI) due to an underlying genetic condition
  1. * Pregnancy
  2. * Patients likely to retain inherent fertility and reproductive function
  3. * Patients deemed high risk for perioperative complications
  4. * Patients 7-17 years of age unable to provide assent (i.e. significant psychiatric problems/cognitive delay)
  5. * Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)

Contacts and Locations

Study Contact

Leslie Appiah, MD
CONTACT
720-926-1970
LESLIE.APPIAH@CUANSCHUTZ.EDU
Jocelyn Phipers
CONTACT
303-724-7807
Jocelyn.Phipers@cuanschutz.edu

Principal Investigator

Leslie Appiah, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Leslie Appiah, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-16
Study Completion Date2031-06-30

Study Record Updates

Study Start Date2021-08-16
Study Completion Date2031-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Ovarian Cancer