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Search / Trial NCT05829928

Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

Launched by UNIVERSITY OF PITTSBURGH · Apr 13, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Fertility Fertility Preservation Infertility Gender Affirming Gender Diverse Non Binary

ClinConnect Summary

This clinical trial is studying how to help individuals in the gender-diverse community preserve their fertility before starting gender-affirming treatments. The researchers want to find better ways to process and freeze testicular tissue, check for the presence of sperm precursors in that tissue, and explore new treatments for infertility. By doing this, they hope to support those who may wish to have biological children in the future.

To be eligible for the study, participants must be assigned male at birth and diagnosed with gender dysphoria. They should be over 9 years old and either currently on or planning to start hormone treatments. Some participants may also be preparing for gender-affirming surgery that involves the removal of the testes, but they must be at least 18 years old. The trial is currently recruiting, and those who participate can expect a careful process to collect and preserve their testicular tissue, helping to ensure their options for future fertility are available. It’s important to note that individuals with certain psychological conditions or serious medical issues may not be eligible to participate.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Category 1 participants must have all criteria listed below:
  • Patient with testes over the age of 9
  • Diagnosed with gender dysphoria; currently on or imminently planning to start gender affirming treatment (hormone blockers or gender-affirming hormones)
  • Have a clinical referral for fertility preservation from their primary care physician
  • Unwilling to undergo natal puberty or, for patients who have gone through puberty, unwilling to discontinue hormone suppression and/or hormone replacement therapy.
  • Category 2 participants only fall into this category if they are undergoing gender-affirming surgery. They must have all criteria listed below:
  • Patient is 18+ years old
  • Diagnosed with gender dysphoria
  • 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.
  • Will be undergoing gender affirming surgery that involves removal of the testes.
  • Exclusion Criteria:
  • Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  • Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Kyle Orwig, PhD

Principal Investigator

University of Pittsburgh/ University of Pittsburgh Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported