Actively Recruiting
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
Led by Vancouver Coastal Health Research Institute · Updated on 2021-10-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vancouver Coastal Health Research Institute
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate hysteroscopic endomyometrial resection as a fertility-preserving treatment for women diagnosed with atypical endometrial hyperplasia or Grade I endometrial cancer who have not responded to anti-hormone therapy. These conditions often require hysterectomy, which affects fertility, so this study focuses on women wishing to maintain their ability to conceive. The approach is multidisciplinary, involving gynecologic oncology, general gynecology, reproductive endocrinology, infertility specialists, and pathology experts. The study involves a single-arm surgical intervention where eligible patients undergo hysteroscopic uterine resection. This procedure removes the abnormal tissue inside the uterus without requiring hysterectomy. Patients considered for this treatment must have had an adequate trial of progestin therapy and be suitable candidates based on evaluations including MRI scans and pathology results. The treatment is performed as a standard gynecologic procedure with careful counseling about risks and complications. Participants are closely monitored before and after the procedure to assess outcomes such as conception rates three years post-resection and local and distant disease control rates at three months and three years. Researchers will also track any complications or side effects over three years. The study includes pre-treatment evaluations, surgical intervention, and long-term follow-up to ensure safety and effectiveness while supporting fertility preservation.
CONDITIONS
Brief Title
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 40 years
- Pathology-confirmed Grade I endometrial endometrioid adenocarcinoma with less than one-third endometrial surface involvement or atypical endometrial hyperplasia
- MRI showing less than one-third myometrial invasion if endometrial cancer is present
- No significant surgical co-morbidities such as pulmonary hypertension or severe cardiac valve disease
- Desire to preserve fertility
- Reasonable chance to conceive based on infertility specialist consultation
- Adequate trial of progesterone therapy (medroxyprogesterone acetate 200 mg/day or megestrol acetate 160 mg/day) for at least 6 months
- Failure of progestin therapy defined as unsuccessful treatment or intolerance to side effects
- Signed informed consent
You will not qualify if you...
- Age 40 years or older
- Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology
- More than one-third involvement of the endometrial surface in Grade I endometrial cancer
- Inability to provide informed consent
- Lack of pathologic confirmation of low-grade carcinoma or atypical hyperplasia
- MRI evidence of myometrial invasion greater than one-third thickness
- MRI evidence of ovarian or adnexal involvement
- Diagnosis of other cancer or medical condition interfering with surgery assessment
- Significant fertility impairment affecting treatment success
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants undergo hysteroscopic uterine resection as a fertility-sparing treatment for early endometrial cancer or atypical hyperplasia after failing progestin therapy.
1 procedure visit (in-person)
Duration - Up to 3 years
Participants are closely monitored after surgery to ensure safety and effectiveness of the treatment, including assessment of disease control and fertility outcomes.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
N
Neeraj Mehra, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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