Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Endometrial thickness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)
排除标准
- •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
研究组 & 干预措施
Dienogest
Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
干预措施: operative hysteroscopy (Procedure)
Dienogest
Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
干预措施: Dienogest (Drug)
Ulipristal acetate
Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
干预措施: operative hysteroscopy (Procedure)
Ulipristal acetate
Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
干预措施: Ulipristal acetate (Drug)
结局指标
主要结局
Endometrial thickness
时间窗: 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
次要结局
- Ovarian follicle dimensions(Change in mm from baseline after farmacological therapy)
- Endometrial appearance(Change from baseline after farmacological therapy)
- Operative time(Within 2 hours after the end of the hysteroscopy)
研究者
Stefano Angioni
Associate Professor
University of Cagliari