Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy

NCT05829928 | Active Not Recruiting

• 1 other identifier: STUDY19070264
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Optimize techniques for processing and cryopreserving testicular tissue.
2. 2.Determine presence and number of germ cells (sperm precursors) in the patients' testicular tissue.
3. 3.Develop next generation cell- and tissue-based therapies for preserving fertility and treating infertility.

Conditions

Gender Dysphoria; Transgender

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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]

• 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]

Study Arms (1)

Cryopreservation

Participants will have gonadal tissue removed and cryopreserved for future fertility applications.

Diagnostic Test: Infectious Disease Testing; Procedure: Gonadal Tissue Removal

Interventions

Infectious Disease Testing DIAGNOSTIC_TEST

Participants will undergo infectious disease testing.

Cryopreservation

Gonadal Tissue Removal PROCEDURE

Removal of gonadal tissue will be done through a surgical procedure.

Cryopreservation

Eligibility Criteria

• Age: 9 Years+
• Sex: male
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients who will undergo gender-affirming treatments and for whom standard of care fertility preservation procedures are not available.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Testicular Tissue

MeSH Terms

Conditions

Gender Dysphoria; Infertility

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Genital Diseases; Urogenital Diseases

Study Officials

• Kyle Orwig, PhD

  University of Pittsburgh/ University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 26, 2023
• Study Start: May 9, 2019
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: We will share IPD with the patients (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
• Access Criteria: De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.

Locations

US (1)