HysterectomyNCT07324967
A Standardized Counseling Approach to Preoperative Education in Transmasculine Individuals Receiving Gender-affirming Surgery
A study testing Educational Handout in people with Hysterectomy and Gender Affirming Surgery, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Gender Affirming Surgery
- What is being tested?
- Educational Handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Erin Wesley, 612-624-9208, obgynresearch@umn.edu
About this study
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.
- Conditions
- Hysterectomy, Gender Affirming Surgery
- Being tested
- Educational Handout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Survey Group | No intervention | Not described |
| Educational Handout + Survey Group | Active comparator | Not described Receives: Other: Educational Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Score
Lower score = less conflict
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start12 Mar 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Johnson, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324967
- Sponsor's protocol ID
- OBGYN-2025-34532
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Counseling Approach to Preoperative Education in Transmasculine Individuals Receiving Gender-affirming Surgery
- ClinicalTrials.gov ID
- NCT07324967
- Acronym / sponsor ID
- OBGYN-2025-34532
- Conditions
- Hysterectomy, Gender Affirming Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survey Group | No intervention | – |
| Educational Handout + Survey Group | Active comparator | Other: Educational Handout |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Handouteducational 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. | Other | Educational Handout + Survey Group |
Primary outcome
Decisional Conflict Score
Time frame: Day 1
Lower score = less conflict
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Johnson principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Handout in people with Hysterectomy and Gender Affirming Surgery, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Wesley (612-624-9208, obgynresearch@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.