NCT05863676

Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 9 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
PROCEDURE	Oophorectomy	Ovary will be removed for fertility preservation.
DIAGNOSTIC_TEST	Infectious Disease Testing	Infectious Disease Testing will be done on participants.

Timeline

• Start date: 2020-07-14
• Primary completion: 2030-07-01
• Completion: 2030-07-01
• First posted: 2023-05-18
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States