ACTIVE_NOT_RECRUITING

Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

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Conditions

Gender DysphoriaTransgenderFertilityFertility PreservationInfertilityGender AffirmingGender DiverseNon-Binary

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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 goal of this study is to learn about fertility preservation in the gender-diverse community. The main objectives it aims to understand are to: 1. Optimize techniques for processing and cryopreserving testicular tissue. 2. Determine presence and number of germ cells (sperm precursors) in the patients' testicular tissue. 3. Develop next generation cell- and tissue-based therapies for preserving fertility and treating infertility.

Official Title

Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

Quick Facts

Study Start:2019-05-09
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05829928

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:9 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient with testes over the age of 9
  2. * Diagnosed with gender dysphoria; currently on or imminently planning to start gender affirming treatment (hormone blockers or gender-affirming hormones)
  3. * Have a clinical referral for fertility preservation from their primary care physician
  4. * Unwilling to undergo natal puberty or, for patients who have gone through puberty, unwilling to discontinue hormone suppression and/or hormone replacement therapy.
  5. * Patient is 18+ years old
  6. * Diagnosed with gender dysphoria
  7. * Unwilling to undergo natal puberty, or for patients who have gone through puberty, be unwilling to discontinue hormone suppression and/or sex steroid (estrogen) therapy.
  8. * Will be undergoing gender affirming surgery that involves removal of the testes.
  1. * Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  2. * Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.

Contacts and Locations

Principal Investigator

Kyle Orwig, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh/ University of Pittsburgh Medical Center

Study Locations (Sites)

Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Kyle Orwig, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh/ University of Pittsburgh Medical Center

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 Date2019-05-09
Study Completion Date2029-05

Study Record Updates

Study Start Date2019-05-09
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

  • Fertility
  • Fertility Preservation
  • Infertility
  • Gender Affirming
  • Gender Diverse
  • Non-Binary

Additional Relevant MeSH Terms

  • Gender Dysphoria
  • Transgender