Recruiting

Fertility Sparing Management

Sponsor:

Vancouver Coastal Health Research Institute

Code:

NCT04362046

Conditions

Endometrial Hyperplasia

Endometrial Cancer

Gynecologic Cancer

Eligibility Criteria

Sex: Female

Age: 19 - 39

Healthy Volunteers: Not accepted

Interventions

Hysteroscopic uterine resection

Study Details

Brief 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.

Conditions

Endometrial Hyperplasia

Endometrial Cancer

Gynecologic Cancer

Study ID

NCT04362046

Start date

Nov 15, 2020

Status verified date

Oct, 2021

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hysteroscopic uterine resection

This is a prospective single-arm surgical intervention trial.

Interventions

Hysteroscopic uterine resection

Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy.

HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications.

Primary outcome measure

  • Conception rate of women attempting pregnancy [ Time Frame: 3 years post-resection ]
  • Overall conception rate [ Time Frame: 3 years post-resection ]
  • Local disease control rate (short-term failure of hysteroscopic resection) [ Time Frame: 3 months post-resection ]
  • Distant disease control rate (long-term failure of hysteroscopic resection) [ Time Frame: 3 years post-resection ]

Central Contacts and Locations

Central contacts

Neeraj Mehra, MD

604-875-5508neeraj.mehra@ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Janice Kwon, MD

604-875-4268janice.kwon@vch.ca

Principal Investigator:

Neeraj Mehra, MD

More Information

Sponsor

Vancouver Coastal Health Research Institute

Last update posted

Oct 20, 2021

Last verified

Oct, 2021

Keywords

  • Fertility preservation
  • Hysteroscopic uterine resection
  • High-dose progesterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Coastal Health Research Institute on 2021-10-20.