Clinical trial NCT03836027: Fertility Desires and Reproductive Needs of Transgender People
Official title: Fertility Preservation and Reproductive Needs of Transgender People: Desires, Attitude and Knowledge of Subjects With Gender Dysphoria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Preservation
Parenting
Gender Dysphoria
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participation to the study will be proposed consecutively to all subjects, fulfilling inclusion criteria, attending in-office follow-up visit for gender dysphoria in the Department of Endocrinology, Diabetology and Nutrition of the University Hospital of Nancy

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-Refusal or incapacity to be involved in the study

Primary outcomes:
measure: Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation
timeFrame: 1 year
Secondary outcomes:
measure: Knowledge of subjects with gender dysphoria on the options of fertility preservation
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Anxiety: State-Trait Anxiety Inventory, STAI-Y
timeFrame: 1 year
measure: Self-esteem : Physical self inventory, 25 items (PSI-25)
timeFrame: 1 year
measure: Depression: Center for Epidemiologic Studies Depression Scale, CES-D
timeFrame: 1 year
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: University Hospital of Nancy
Study officials:
References: