Gender DysphoriaNCT05829928
Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
An observational study of Gender Dysphoria and Transgender, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 years and older, men only
- Conditions the study is for
- Gender Dysphoria, Transgender
- What is being tested?
- Infectious Disease Testing and Gonadal Tissue Removal
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2019to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- Men only
- Child, Adult, Older adult
Study population: Eligible patients who will undergo gender-affirming treatments and for whom standard of care fertility preservation procedures are not available.
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
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:
- Optimize techniques for processing and cryopreserving testicular tissue.
- Determine presence and number of germ cells (sperm precursors) in the patients' testicular tissue.
- Develop next generation cell- and tissue-based therapies for preserving fertility and treating infertility.
Read the 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
- Being tested
- Infectious Disease Testing, Gonadal Tissue Removal
- Keywords
- Fertility, Fertility Preservation, Infertility, Gender Affirming, Gender Diverse, Non-Binary
- Medical subject headings
- Gender Dysphoria, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infectious Disease TestingDiagnostic test
Participants will undergo infectious disease testing.
Gonadal Tissue RemovalProcedure or surgery
Removal of gonadal tissue will be done through a surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cryopreservation | Participants will have gonadal tissue removed and cryopreserved for future fertility applications. Receives: Diagnostic Test: Infectious Disease Testing; Procedure: Gonadal Tissue Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [10 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start9 May 2019
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Orwig, University of Pittsburgh
- Investigators
- Kyle Orwig, PhD, Principal investigator, University of Pittsburgh/ University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829928
- Sponsor's protocol ID
- STUDY19070264
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will publish individual participant data. The investigators will also report each individual participant's data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
- ClinicalTrials.gov ID
- NCT05829928
- Acronym / sponsor ID
- STUDY19070264
- Conditions
- Gender Dysphoria, Transgender
- Keywords
- Fertility, Fertility Preservation, Infertility, Gender Affirming, Gender Diverse, Non-Binary
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Optimize techniques for processing and cryopreserving testicular tissue.
- Determine presence and number of germ cells (sperm precursors) in the patients' testicular tissue.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryopreservation | – | Diagnostic Test: Infectious Disease Testing, Procedure: Gonadal Tissue RemovalParticipants will have gonadal tissue removed and cryopreserved for future fertility applications. |
Who may qualify
- Ages
- 9 years and older
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients who will undergo gender-affirming treatments and for whom standard of care fertility preservation procedures are not available.
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infectious Disease TestingParticipants will undergo infectious disease testing. | Diagnostic test | Cryopreservation |
| Gonadal Tissue RemovalRemoval of gonadal tissue will be done through a surgical procedure. | Procedure or surgery | Cryopreservation |
Primary outcome
Optimization of testicular tissue/cell cryopreservation techniques
Time frame: [10 years]
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.
To determine presence and number of germ cells (sperm precursors) in the patients' testicular tissue
Time frame: [10 years]
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will publish individual participant data. The investigators will also report each individual participant's data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Orwig, PhD principal investigator
University of Pittsburgh/ University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria and Transgender, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization of testicular tissue/cell cryopreservation techniques (time frame: [10 years]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.