Fertility Desires and Reproductive Needs of Transgender People (PaFer)

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

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.

Study Overview

• Status: Completed
• Conditions: Gender Dysphoria; Parenting; Fertility Preservation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Vandoeuvre Les Nancy, France, 54000
    • University Hospital of Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproductive desires and attitudes of transgender and gender nonconforming people towards fertility preservation	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of subjects with gender dysphoria on the options of fertility preservation	Description of the construct and its evaluation is detailed in the section "primary outcome measure" as follows: 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.	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	Questionnaire (Short form 36 health survey) The SF-36 is a generic quality of life self-questionnaire with 36 items grouped in 8 dimensions (physical functioning, limitations due to physical state, pain, mental health, limitations due to mental state, social health, vitality and global health). For each dimension a quality of life score is calculated and normalized between 0 (worst possible QoL) and 100 (best QoL possible).	1 year
Anxiety: State-Trait Anxiety Inventory, STAI-Y	The STAI-Y assesses anxiety as a personality trait and as a specific emotional response to a situation. The first part, STAI-Y-1, consists of 20 sentences assessing the current emotional state of the subject. The second part, STAI-Y-2, consists of 20 sentences assessing the subject's usual emotional state.; Each answer to an item in the STAI-Y is scored from 1 to 4, with 1 indicating the lowest degree of anxiety and 4 the highest degree of anxiety.; In the STAI-Y-1, the subject indicates the intensity of his feelings on a 4-point Likert scale ranging from "not at all" to "many". In the STAI-Y-2, the subject indicates on a 4-point Likert scale ranging from "almost never" to "almost always", a frequency at which he usually feels the symptoms listed.; To obtain the score for the STAI-Y-1, the scores for the 20 items (1 to 20) are summed. To obtain the STAI-Y-2 score, the scores for the 20 items (21 to 40) are summed. Each score can therefore vary from 20 to 80.	1 year
Self-esteem : Physical self inventory, 25 items (PSI-25)	The PSI-25 is an inventory of self-esteem relating to the body domain.; This tool consists of 6 scales: at the general level, the overall self-esteem scale, at the physical domain level: the perceived physical value scale, and at the subdomain level, 4 subscales: the fitness, athletic competence, physical appearance and strength. It has 25 items; The subject responds on the Likert scale in 6 increasing degrees (it looks like me 1: not at all, 2: very little, 3: a little, 4: enough, 5: a lot, 6: quite).; The score ranges from 5 to 30 for each scale, total score is averaged.	1 year
Depression: Center for Epidemiologic Studies Depression Scale, CES-D	The CES-D assesses the frequency and severity of depressive symptoms presented by the general population. The questionnaire has 20 items.; The subject indicates on a 4-point Likert scale ranging from "almost never" to "almost always", a frequency at which he usually feels the symptoms listed.; Score is calculated from 0 to 60 (maximum score indicating strong expression of symptoms)	1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: 2018-A03374-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No