跳至主要内容
临床试验/NCT03836027
NCT03836027已完成不适用

Fertility Preservation and Reproductive Needs of Transgender People: Desires, Attitude and Knowledge of Subjects With Gender Dysphoria

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation

研究概览

简要总结

Majority of transgender and gender nonconforming people seeking medical care are in pubertal and reproductive age. Cross-sex hormones may compromise fertility especially when preceded by puberty blocking regimen. Our current understanding on reproductive needs of transgender persons is insufficient.

The guidelines of Endocrine Society and the World Professional Association for Transgender Health prompt the health professionals to provide information on fertility risk and fertility preservation options before initiating hormonal treatment. Currently, no clear tools are available for healthcare professionals. Among several challenges for clinical care are a low clinical awareness, a lack of suitable psycho-educational instruments addressing fertility values that can be used to facilitate discussion between transgender persons and healthcare providers, a lack of established methods for fertility preservation in prepubertal youth, and a lack of long-term data regarding reproductive function, psychological and societal outcomes in this population. Likewise, current data are sparse regarding the experience of transgender and gender nonconforming people with fertility preservation.

Our aim is to describe desires, attitudes and knowledge of transgender and gender nonconforming people regarding fertility preservation wishes and reproductive needs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Follow-up in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy
  • Gender dysphoria according to the ICD 11
  • Voluntary, informed consent to participate in research
  • Compulsory affiliation to the social security system

排除标准

  • Refusal or incapacity to be involved in the study

结局指标

主要结局

Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation

时间窗: 1 year

A cross-sectional anonymous survey developed in the University Hospital of Nancy. Content validity of the questionnaire is endorsed by 2 endocrinologists specialized in transgender health (EF, VP). The first part provides general information on the characteristics of respondents (9 items). The second part concerns knowledge on fertility preservation (10 items), parental desires and constraints (8 items) and attitudes on fertility preservation issues (6 items). A descriptive analysis of the sample will be done using mean and standard deviation (or median and interquartile range) for quantitative variables, and counts and percentages for qualitative variables. The approval by the Institutional Review Board of the University Hospital of Nancy and the registration at French National Commission for Data Protection and Liberties are underway.

次要结局

  • Anxiety: State-Trait Anxiety Inventory, STAI-Y(1 year)
  • Self-esteem : Physical self inventory, 25 items (PSI-25)(1 year)
  • Depression: Center for Epidemiologic Studies Depression Scale, CES-D(1 year)
  • generic quality of life: physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health(1 year)
  • Knowledge of subjects with gender dysphoria on the options of fertility preservation(1 year)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验