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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dienogest | Experimental | Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die |
|
| Ulipristal acetate | Experimental | Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| operative hysteroscopy | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C023635 | dienogest |
| C555622 | ulipristal acetate |
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|
| Dienogest | Drug | 21 days administration of dienogest 2 mg/die |
|
|
| Ulipristal acetate | Drug | 21 days administration of ulipristal acetate 5 mg/die |
|
|
| 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 |