Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Study Overview
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Brief Summary
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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.

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Procedure: operative hysteroscopy
* Drug: Dienogest
* Drug: Ulipristal acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dienogest<br>Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die | Procedure: operative hysteroscopy<br>* 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.<br>Drug: Dienogest<br>* 21 days administration of dienogest 2 mg/die<br>* Other names: Visanne;|
| Experimental: Ulipristal acetate<br>Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die | Procedure: operative hysteroscopy<br>* 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.<br>Drug: Ulipristal acetate<br>* 21 days administration of ulipristal acetate 5 mg/die<br>* Other names: Esmya;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial thickness | 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 |
| --- | --- | --- |
| Ovarian follicle dimensions | 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 | 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 | 
| Operative time | It will be expressed in minutes | Within 2 hours after the end of the hysteroscopy |