Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Uterine Fibroids Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02440750
• Other study ID #: HYSTERO
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 18, 2015
• Last updated: March 8, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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
• Ulipristal acetate
21 days administration of ulipristal acetate 5 mg/die

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Operative time	It will be expressed in minutes	Within 2 hours after the end of the hysteroscopy	Yes