Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy

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. To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
2. To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy

Study Overview

• Status: Active, not recruiting
• Conditions: Gender Dysphoria; Transgender
• Intervention / Treatment: Procedure: Oophorectomy; Diagnostic test: Infectious Disease Testing

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 transgender male patients (transitioning female to male) 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 transgender male patients, medical treatment is primarily comprised of testosterone, which is often preceded by GnRH agonists (such as leuprolide acetate) to reduce endogenous estrogen 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 GnRH agonist and/or testosterone therapy, fertility preservation counseling is an essential aspect of their care. Egg preservation does require the individual to undergo their natal puberty, and for many trans-males, this is undesirable and even contra-indicated from mental health standpoint, as the suicide rate for transgender youth is 10-times the national average. Ovarian tissue cryopreservation is an alternative option for transgender male patients who desire pubertal blockade and testosterone but have not yet gone through female puberty and are therefore not producing mature eggs.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryopreservation; Participants will have their gonadal tissue cryopreserved.	Procedure: Oophorectomy; Ovary will be removed for fertility preservation.; Diagnostic test: Infectious Disease Testing; Infectious Disease Testing will be done on participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.	Without undergoing puberty in one's natal sex, there are no standard of care fertility preservation options available for these patients. The study will aim to optimize techniques for cryopreservation of ovarian tissues by utilizing the best scientific standards for cryopreservation.	[10 years]
To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy.	For transgender male patients, medical treatment is primarily comprised of testosterone, which is often preceded by GnRH agonists (such as leuprolide acetate) to reduce endogenous estrogen production. There are theoretical concerns about the effects of long-standing hormonal treatment on the gonads and future fertility potential. The study aims to determine whether factors such as gender-affirming treatment affects the ovarian tissue and follicles by examining tissue donated to research.	[10 years]

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Kyle Orwig, PhD, University of Pittsburgh/ University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Infertility; Ovary; Fertility; Fertility Preservation; Gender Diverse; Gender Affirming; Non-Binary
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: STUDY19060046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
• IPD Sharing Time Frame: We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No