Ovarian Tissue Cryopreservation in the Setting of Gender-affirming Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
研究概览
简要总结
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:
- To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
- To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 —(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To optimize techniques for cryopreservation of ovarian tissues, including determining efficacy of cryopreservation techniques.
时间窗: [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.
To investigate factors affecting ovarian tissue and follicles, such as previous treatment with leuprolide acetate, or hormone therapy.
时间窗: [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.
次要结局
未报告次要终点
研究者
Kyle Orwig
Professor
University of Pittsburgh
