Clinical trial for Endometrial Hyperplasia
Official title Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
ClinicalTrials.gov ID: NCT04362046
What this study is testing
- What it's testing
- The study aims to see if hysteroscopic endomyometrial resection can treat these conditions while keeping fertility intact.
- Who it's for
- Women with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti‑hormone therapy and want to keep the ability to have children.
- What's involved
- Participants will undergo a hysteroscopic surgery that removes the affected tissue. They will have pre‑ and post‑operative visits and imaging or biopsy tests to monitor the outcome.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 39, women only
You may be able to join if
- Age less than 40 years
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Age less than 40 years
- 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
- Medroxyprogesterone acetate (Provera; 200mg/day)
- Megestrol acetate (Megace; 160mg/day)
- Adequate duration: 6 months
- Unsuccessful eradication of hyperplasia or cancer in the uterus
- Intolerance to the side effects
- Signed informed consent
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.