Tests surgery to remove uterine lining to preserve fertility in young women
Tests a uterine lining removal procedure in young women with endometrial hyperplasia or cancer.
Plain-language title generated from the registry record
Registry title: Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Key facts
- Where
- Vancouver, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 39 years old?
Source: NCT04362046, who can take part
Where in Canada
- Vancouver General HospitalVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vancouver Coastal Health Research Institute
- Trial code
- NCT04362046
- Record updated
- 20 October 2021
- Original description
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.Read full original descriptionShow less
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
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.
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; 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:; 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 effects; Signed informed consent.
Exclusion: 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; 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.
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:.