Evaluate the Therapy of Large Ovarian Endometrioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
研究概览
简要总结
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.
Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.
In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.
This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.
The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometrioma size ≥ 6cm determined by MRI or ultrasonography
- •Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis.
- •Cyst single or bilateral
排除标准
- •Cyst with radiographic or macroscopic in laparoscopy atypia
- •Pregnancy
- •Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg)
- •Patient with contraindication to laparoscopy
- •Patient with contraindication to general anesthesia
- •Subject refusing to participate in the study
结局指标
主要结局
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
时间窗: at 3 months
次要结局
- The impact of the ovarian reserve postoperative(at 3 months)
- The number of re-operation(at 4 months)