Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

Gender Dysphoria Clinical Trial

Official title:

Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829928
• Other study ID #: STUDY19070264
• Status: Recruiting
• Start date: May 9, 2019
• Est. completion date: May 2029

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Rachel Neelley, BA
• Phone: 4126417475
• Email: fertilitypreservation[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Gender: Male
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gender Dysphoria
• Transgender

Intervention

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.

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimization of testicular tissue/cell cryopreservation techniques	Testicular tissue will be used to isolate a suspension of testicular cells using a series of enzymatic digestions, washes, and filtrations. Testicular cells donated to the research pool will be frozen using varying cryopreservation methods and thawed to determine the efficacy of the freeze/thaw techniques. The concentration and number of recovered spermatogonial stem cells in the thawed cells will be determined using a human-to-nude mouse xenotransplantation assay. Recovery of spermatogonial stem cells will be compared to the concentration and number prior to cryopreservation using the same assay. Data gathered from this research will assist in identifying and overcoming some of the challenges to successful freezing and thawing of cells for future use by the patient.	[10 years]
Primary	To determine presence and number of germ cells (sperm precursors) in the patients' testicular tissue	The number of stem cells in the developing testis in the humans is currently not established. Therefore, a small piece of testicular tissue from each patient (from the research portion) will be fixed in 4% of paraformaldehyde (PFA) and stained for known germ cell markers in order to count the number of stem cells in the patient tissue.	[10 years]