Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy

NCT05863676 | Active Not Recruiting

• 1 other identifier: STUDY19060046
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
2. 2.To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy

Conditions

Gender Dysphoria; Transgender

Keywords

Fertility; Fertility Preservation; Infertility; Gender Affirming; Gender Diverse; Non-Binary; Ovary

Outcome Measures

Primary Outcomes (2)

• 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]

Study Arms (1)

Cryopreservation

Participants will have their gonadal tissue cryopreserved.

Procedure: Oophorectomy; Diagnostic Test: Infectious Disease Testing

Interventions

Oophorectomy PROCEDURE

Ovary will be removed for fertility preservation.

Cryopreservation

Infectious Disease Testing DIAGNOSTIC_TEST

Infectious Disease Testing will be done on participants.

Cryopreservation

Eligibility Criteria

• Age: 9 Years+
• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Ovarian Tissue

MeSH Terms

Conditions

Gender Dysphoria; Infertility

Interventions

Ovariectomy

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Kyle Orwig, PhD

  University of Pittsburgh/ University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 18, 2023
• Study Start: July 14, 2020
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

US (1)