Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT05863676
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
This study is active but is not currently recruiting participants.
Notify Me9 year and older
Female
Observational
Pittsburgh, Pennsylvania, 15213, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Two Categories of participants will be eligible for this study.
Category 1 participants must have all criteria listed below:
Category 2 participants only fall into this category if they are undergoing gender-affirming surgery. They must have all criteria listed below:
Exclusion criteria
Ovary will be removed for fertility preservation.
Infectious Disease Testing will be done on participants.
Time frame: [10 years]
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.
Time frame: [10 years]
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.
University of Pittsburgh
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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