Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 39
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Neeraj Mehra, MD
neeraj.mehra@ubc.ca
604-875-5508
Time Frame
Start Date: 2020-11-15
Estimated Completion Date: 2028-07
Participants
Target number of participants: 30
Treatments
Experimental: Hysteroscopic uterine resection
This is a prospective single-arm surgical intervention trial.
Related Therapeutic Areas
Sponsors
Collaborators: University of British Columbia
Leads: Vancouver Coastal Health Research Institute

This content was sourced from clinicaltrials.gov