NCT03836027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2021

Completed
Last Updated

February 9, 2022

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

January 28, 2019

Last Update Submit

February 8, 2022

Conditions

Fertility PreservationParentingGender Dysphoria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Knowledge of subjects with gender dysphoria on the options of fertility preservation

    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

  • 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

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Refusal or incapacity to be involved in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy

Vandœuvre-lès-Nancy, 54000, France

Location

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 11, 2019

Study Start

April 11, 2019

Primary Completion

April 6, 2021

Study Completion

April 6, 2021

Last Updated

February 9, 2022

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Locations

FR(1)