A Standardized Counseling Approach to Preoperative Education in Transmasculine Individuals Receiving Gender-affirming Surgery

April 2, 2026 updated by: University of Minnesota
The intervention will be an educational handout provided to a randomized cohort of patients that reviews the benefits and risks of retaining ovaries vs removing them. This educational handout will be provided prior to the surgical consultation at the time of the initial survey.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Any transgender or non-binary individual
  • Age 18-65
  • Assigned female at birth who desires a gender-affirming hysterectomy with or without oophorectomy
  • English-speaking

Exclusion Criteria:

  • Non-transgender individuals
  • Any transgender individual who has already had a bilateral oophorectomy
  • Any transgender person who was born without ovaries or a uterus
  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Survey Group
Active Comparator: Educational Handout + Survey Group
Other: Educational Handout
educational handout provided to a randomized cohort of patients that reviews the benefits and risks of retaining ovaries vs removing them. This educational handout will be provided prior to the surgical consultation at the time of the initial survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Score
Time Frame: Day 1
Lower score = less conflict
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Andrea Johnson, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OBGYN-2025-34532

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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