No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
19 – 39
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Vancouver Coastal Health Research Institute · Other
Who this trial is looking for
This trial is looking for women under 40 who have been diagnosed with atypical endometrial hyperplasia or early-stage endometrial cancer and wish to keep their fertility. Participants will undergo a specific type of surgery after a trial of hormone therapy.
Are You a Good Fit for This Trial?
Must be takingMedroxyprogesterone acetateMegestrol acetate
You may be able to join if
I am under 40 years old
I have been diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer
My biopsy shows low-grade endometrial cancer
I have completed at least 6 months of high-dose progestin therapy
I want to preserve my fertility
I have a reasonable chance to conceive based on a fertility specialist's consultation
I do not have significant surgical health issues
I have signed informed consent
You may not be able to join if
I am 40 years old or older
I have high-grade endometrial cancer
More than one-third of my endometrial surface is affected by cancer
I cannot provide informed consent
I have not been confirmed to have low-grade endometrial cancer or atypical hyperplasia
My MRI shows more than one-third myometrial invasion
I have evidence of tumor involvement in ovaries or other areas
I have another cancer or serious medical issue affecting my surgery
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
All candidates for this protocol must have an adequate trial of anti-hormone therapy prior to hysteroscopic resection. In cases of EC, the minimum trial is 6 months of high-dose progestin. In cases of AH, being that this is a benign condition (pre-malignant), patients may not require a full 6 months…
All candidates for this protocol must have an adequate trial of anti-hormone therapy prior to hysteroscopic resection. In cases of EC, the minimum trial is 6 months of high-dose progestin. In cases of AH, being that this is a benign condition (pre-malignant), patients may not require a full 6 months of anti-hormone therapy. All patients must have a pre-HR hysteroscopic evaluation to confirm that they are suitable candidates for this study. Patients being considered for the experimental intervention (hysteroscopic resection) will be reviewed and discussed by the study committee in order to ensure that the following criterion are met in order to proceed with the surgical resection:
Inclusion criteria:
* Age less than 40 years
* Pathologist confirmed biopsy evidence of one of the following:
1. Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved.
2. Atypical endometrial hyperplasia (AH)
* MRI demonstrating less than 1/3 myometrial invasion if the patient has EC
* Absence of significant surgical co-morbidities e.g. pulmonary hypertension, significant cardiac valvular disease, or contraindication to surgery.
* Desire to preserve fertility
* Reasonable chance to conceive based on consultation with an infertility specialist
* Adequate dose and duration of progesterone therapy prior to enrolment:
* Adequate dose:
1. Medroxyprogesterone acetate (Provera; 200mg/day)
2. Megestrol acetate (Megace; 160mg/day)
* Adequate duration: 6 months
* Failure of progestin therapy defined as:
1. Unsuccessful eradication of hyperplasia or cancer in the uterus
2. Intolerance to the side effects
* Signed informed consent
Exclusion criteria:
* 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 consent
* 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
* The diagnosis of another cancer or medical condition that would interfere with the assessment of the hysteroscopic surgery success rates.
* Significant underlying fertility impairment that would significantly interfere with the success rate of HR
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