Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

March 8, 2016 updated by: Stefano Angioni, University of Cagliari
The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)

Exclusion Criteria:

  • pregnancy
  • other hormonal therapy in the previous 8 weeks
  • hepatic or renal impairment
  • any medical condition that would increase the surgical risk
  • refusal or unable to sign written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dienogest
Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
Procedure: operative hysteroscopy
Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
Drug: Dienogest
21 days administration of dienogest 2 mg/die
Other Names:
  • Visanne
Experimental: Ulipristal acetate
Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
Procedure: operative hysteroscopy
Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
Drug: Ulipristal acetate
21 days administration of ulipristal acetate 5 mg/die
Other Names:
  • Esmya

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness
Time Frame: Change in mm from baseline after farmacological therapy
We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
Change in mm from baseline after farmacological therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Within 2 hours after the end of the hysteroscopy
It will be expressed in minutes
Within 2 hours after the end of the hysteroscopy
Ovarian follicle dimensions
Time Frame: Change in mm from baseline after farmacological therapy
We perform a transvaginal ultrasound (baseline) and we measure the maximum diameter of follicles; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
Change in mm from baseline after farmacological therapy
Endometrial appearance
Time Frame: Change from baseline after farmacological therapy
We perform a diagnostic hysteroscopy (baseline) and we describe the endometrial appearance; at the time of surgery (operative hysteroscopy) we describe the endometrial appearance after pharmacological treatment
Change from baseline after farmacological therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYSTERO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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