Fertility preservation for gender-diverse individuals through ovarian tissue cryopreservation
Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy
This study is testing new ways to help gender-diverse individuals preserve their fertility by freezing ovarian tissue and looking at how past treatments might affect their reproductive health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 9 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05863676 on ClinicalTrials.gov |
What this trial studies
This study aims to explore fertility preservation techniques specifically for individuals experiencing gender dysphoria. It focuses on optimizing ovarian tissue cryopreservation methods and understanding the impact of prior treatments, such as hormone therapy and GnRH agonists, on ovarian health. The research highlights the importance of fertility counseling for transgender male patients who may face challenges related to their reproductive health due to medical treatments. By investigating these factors, the study seeks to improve fertility preservation options for the gender-diverse community.
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 or are currently undergoing gender-affirming treatment.
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 enhance fertility preservation options for transgender individuals, allowing them to have biological children in the future.
How similar studies have performed: While the approach of ovarian tissue cryopreservation is established, this specific focus on the gender-diverse population is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Two Categories of participants will be eligible for this study. Category 1 participants must have all criteria listed below: * Patient with ovaries 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 ovaries. 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 E Neelley, BA
- Email: fertilitypreservation@upmc.edu
- Phone: 412-641-7475
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.