Fertility preservation for gender-diverse individuals through testicular tissue cryopreservation
Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
This study is testing new ways to freeze testicular tissue to help gender-diverse individuals preserve their fertility before starting gender-affirming treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 9 Years and up |
| Sex | Male |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05829928 on ClinicalTrials.gov |
What this trial studies
This study aims to explore fertility preservation techniques for individuals with gender dysphoria by optimizing methods for processing and cryopreserving testicular tissue. It seeks to assess the presence and quantity of germ cells in the tissue and develop innovative therapies for preserving fertility. The research emphasizes the importance of fertility preservation counseling prior to the initiation of gender-affirming treatments, particularly for those who may not wish to undergo natal puberty. By focusing on this population, the study addresses a critical aspect of care that has been historically overlooked.
Who should consider this trial
Good fit: Ideal candidates include individuals over the age of 9 diagnosed with gender dysphoria who are planning to start gender-affirming treatment and have a referral for fertility preservation.
Not a fit: Patients who are not diagnosed with gender dysphoria or those who do not wish to pursue fertility preservation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide gender-diverse individuals with viable options for preserving their fertility before undergoing gender-affirming treatments.
How similar studies have performed: While fertility preservation in gender-diverse populations is an emerging field, previous studies have indicated the importance of addressing this need, suggesting potential for success in similar approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kyle Orwig, PhD — University of Pittsburgh/ University of Pittsburgh Medical Center
- Study coordinator: Rachel Neelley, BA
- Email: fertilitypreservation@upmc.edu
- Phone: 4126417475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.