Testing Hysteroscopic uterine resection for endometrial hyperplasia
Official title: Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
- 1 group
- One site, in Vancouver
- Recruiting
Interventions
- Medical procedure
Hysteroscopic uterine resection
Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy. HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age less than 40 years
- +Pathologist confirmed biopsy evidence of one of the following:
- +Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved.
- +Atypical endometrial hyperplasia (AH)
- +MRI demonstrating less than 1/3 myometrial invasion if the patient has EC
- +Desire to preserve fertility
- +Reasonable chance to conceive based on consultation with an infertility specialist
- +Adequate dose and duration of progesterone therapy prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →:
- +Adequate dose:
- +Medroxyprogesterone acetate (Provera; 200mg/day)
- +Megestrol acetate (Megace; 160mg/day)
- +Adequate duration: 6 months
- +Failure of progestin therapy defined as:
- +Unsuccessful eradication of hyperplasia or cancer in the uterus
- +Intolerance to the side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →
- +Signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Absence of significant surgical co-morbidities e.g. pulmonary hypertension, significant cardiac valvular disease, or contraindication to surgery.
Exclusion
- −Age 40 years and over
- −Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology
- −Greater than 1/3 involvement of the endometrial surface in patients with Grade I EC
- −Women who are not able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Women without pathologic confirmation of low-grade endometrioid carcinoma or AH
- −Myometrial invasion on MRI greater than 1/3 total myometrial thickness.
- −MRI evidence of ovarian or adnexal involvement
- −Significant underlying fertility impairment that would significantly interfere with the success rate of HR
- −The diagnosis of another cancer or medical condition that would interfere with the assessment of the hysteroscopic surgery success rates.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Hysteroscopic uterine resection.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 19 years to 39 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around July 2028.
The main measurement is taken over: 3 years post-resection.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Conception rate of women attempting pregnancy — measured over 3 years post-resection.
Overall conception rate — measured over 3 years post-resection.
Local disease controlControl groupThe group a new treatment is measured against.Read more → rate (short-term failure of hysteroscopic resection) — measured over 3 months post-resection.
Distant disease control rate (long-term failure of hysteroscopic resection) — measured over 3 years post-resection.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04362046 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Hysteroscopic uterine resectionProcedure
Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy. HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 19 years to 39 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 19 years to 39 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 years post-resection.
The study as a whole is currently expected to finish around 2028-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.