Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Phase 4

• Conditions: Uterine Fibroids
• Interventions: Procedure: operative hysteroscopy; Drug: Dienogest; Drug: Ulipristal acetate

• Registration Number: NCT02440750
• Lead Sponsor: University of Cagliari

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09
• Study Start: 2016-06
• Primary Completion: 2017-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest	operative hysteroscopy	Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
Ulipristal acetate	operative hysteroscopy	Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
Dienogest	Dienogest	Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
Ulipristal acetate	Ulipristal acetate	Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die

Primary Outcome Measures

Name	Time	Method
Endometrial thickness	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

Secondary Outcome Measures

Name	Time	Method
Ovarian follicle dimensions	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
Endometrial appearance	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
Operative time	Within 2 hours after the end of the hysteroscopy	It will be expressed in minutes