A Standardized Counseling Approach to Preoperative Educat... | NCT07324967

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

NCT07324967

Sponsor

University of Minnesota

Status

Recruiting

Last Update Posted

Apr 3, 2026Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Hysterectomy
Gender Affirming Surgery

Interventions

Educational Handout

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2026Actual

Primary Completion Date

Jul 31, 2028Estimated

Completion Date

Jul 31, 2028Estimated

First Submitted Date

Dec 23, 2025

First Submission Date that Met QC Criteria

Dec 23, 2025

First Posted Date

Jan 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survey Group	No Intervention
Educational Handout + Survey Group	Active Comparator		Other: Educational Handout

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational Handout	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erin Wesley	Contact	612-624-9208		obgynresearch@umn.edu

Overall Officials

Name	Affiliation	Role
Andrea Johnson	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota	Recruiting	Minneapolis	Minnesota	55455	United States