Uterine Fibroids
Conditions
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.
Interventions
PROCEDUREoperative 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.
DRUGDienogest
21 days administration of dienogest 2 mg/die
DRUGUlipristal acetate
21 days administration of ulipristal acetate 5 mg/die
Sponsors
University of Cagliari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed