The Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Inner Lining of Ovarian Endometriomas After Laparoscopic Cystectomy: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Anti-Müllerian hormone (AMH) serum levels
研究概览
简要总结
Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques.
The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve.
The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •regular menstrual cycles
- •unilateral endometrioma greater than 35 mm
- •no gynecological surgery 3-6 months before surgery
- •no hormonal therapy 1 month before surgery
排除标准
- •previous surgery for endometriosis
- •hormone therapy in the month before the current surgery
- •coagulation disorders
- •ongoing pregnancy
- •pelvic inflammatory disease
- •malignant disorders
- •cysts otherwise
- •Gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up
- •BMI≥ 30 kg/m2
- •endocrinological disorders
- •unable or unwilling to give written consent
结局指标
主要结局
Anti-Müllerian hormone (AMH) serum levels
时间窗: Change from AMH serum levels at 3 months after surgery
次要结局
- Antral follicular count (AFC)(Change from AFC at 3 months after surgery, during early follicular phase)
研究者
Stefano Angioni
Associate Professor
University of Cagliari