Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy

NCT ID: NCT05863676

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2030-07-31

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. 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

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.

Conditions

Gender Dysphoria; Transgender

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cryopreservation

Participants will have their gonadal tissue cryopreserved.

Oophorectomy

Intervention Type: PROCEDURE

Ovary will be removed for fertility preservation.

Infectious Disease Testing

Intervention Type: DIAGNOSTIC_TEST

Infectious Disease Testing will be done on participants.

Interventions

Oophorectomy

Ovary will be removed for fertility preservation.

Intervention Type: PROCEDURE

Infectious Disease Testing

Infectious Disease Testing will be done on participants.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Kyle Orwig

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Orwig, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh/ University of Pittsburgh Medical Center

Locations

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19060046

Identifier Type: -

Identifier Source: org_study_id