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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryopreservation | Participants will have gonadal tissue removed and cryopreserved for future fertility applications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infectious Disease Testing | Diagnostic Test | Participants will undergo infectious disease testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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] |
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Inclusion Criteria:
Category 1 participants must have all criteria listed below:
Category 2 participants only fall into this category if they are undergoing gender-affirming surgery. They must have all criteria listed below:
Exclusion Criteria:
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Eligible patients who will undergo gender-affirming treatments and for whom standard of care fertility preservation procedures are not available.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Orwig, PhD | University of Pittsburgh/ University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
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.
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.
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.
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Testicular Tissue
| Gonadal Tissue Removal | Procedure | Removal of gonadal tissue will be done through a surgical procedure. |
|