NCT05829928

Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Male
• Age: 9 Years
• Healthy volunteers: —

Summary

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.

Detailed description

Fertility preservation is an important aspect of care for all patients who may have their fertility compromised secondary to disease, medical treatments, age or other circumstances, including treatments for gender dysphoria. An increasing number of gender diverse patients are presenting to fertility clinics for fertility preservation. Studies indicate that parenthood is important for this patient population. Therefore, both the Endocrine Society and the World Professional Association for Transgender Health (WPATH) recommend that fertility preservation be discussed with all patients prior to initiation of medical treatments for gender dysphoria. For gender diverse patients, medical treatment is primarily comprised of estradiol, which is often preceded by GnRH agonists (such as leuprolide acetate, histrelin) to reduce endogenous testosterone production. There are theoretical concerns about the effects of long-standing hormonal treatment on the gonads and future fertility potential. Regardless of the timing of initiation of hormone suppression and/or estradiol therapy, fertility preservation counseling is an essential aspect of their care. Sperm preservation does require the individual to undergo their natal puberty, and for many transgender patients, this is undesirable and even contra-indicated from mental health standpoint, as the suicide rate for transgender youth is 10-times the national average. Testicular tissue cryopreservation is an alternative option for transgender patients who desire pubertal blockade and estradiol but have not yet initiated sperm production (spermarche) to preserve their fertility. Spermarche typically occurs at sexual maturity rating (SMR) 4 and pubertal blockade is offered as early as SMR 2.

Conditions

• Gender Dysphoria
• Transgender

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Infectious Disease Testing	Participants will undergo infectious disease testing.
PROCEDURE	Gonadal Tissue Removal	Removal of gonadal tissue will be done through a surgical procedure.

Timeline

• Start date: 2019-05-09
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2023-04-26
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States