NCT07324967

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress12%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

December 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

December 23, 2025

Last Update Submit

December 23, 2025

Conditions

HysterectomyGender Affirming Surgery

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict Score

    Lower score = less conflict

    Day 1

Study Arms (2)

Survey Group

NO INTERVENTION

Educational Handout + Survey Group

ACTIVE COMPARATOR
Other: Educational Handout

Interventions

Educational HandoutOTHER

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.

Educational Handout + Survey Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Meredith Wise

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Wesley

CONTACT

612-624-9208obgynresearch@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 8, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations

US(1)