NCT06098781

Brief Summary

The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth). The main question it aims to answer are: • What is the experienced effect of gynaecological gender-affirming surgeries Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

October 19, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

hysterectomycolpectomyvaginectomytubectomypatient-reported outcome measure

Outcome Measures

Primary Outcomes (2)

  • Experienced effect on gender dysphoria

    On a scale of -5 to +5 the experienced effect on gender dysphoria

    3& 9 months

  • Experienced effect on gender dysphoria measured by GCLS

    Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively

    9 & 18 months

Secondary Outcomes (7)

  • Experienced effect on psychological well being

    3 & 9 months

  • Experienced effect on confidence

    3& 9 months

  • Experienced effect on sexual experience

    3& 9 months

  • Surgical satisfaction

    3& 9 months

  • Impact of health on satisfaction of life

    3 & 9 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTrans-masculine or non-binary individuals (assigned female at birth)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trans-masculine or non-binary individuals (assigned female at birth) with wish to undergo gynaecological gender-affirming surgeries

You may qualify if:

  • assigned female at birth
  • scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)

You may not qualify if:

  • age below 18 y/o
  • surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, Location VU Medical Center

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 25, 2023

Study Start

September 2, 2022

Primary Completion

February 1, 2024

Study Completion

June 1, 2025

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations