A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The recurrent rate of advanced endometriosis
研究概览
简要总结
The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.
详细描述
In order to decrease endometriosis recurrence and enhance pregnancy rate after surgical therapy, it has been proposed to use a post-surgical gonadotropin-releasing-hormone agonist (GnRHa) treatment. Data on the short-term recurrence of advanced endometriosis is rare. Although operative treatment has resulted in increasing pregnancy rate comparing non surgery management for moderate to severe endometriosis, very few data of spontaneous pregnancy rate are available comparing GnRHa treatment or expectant management after surgery treatment. In this situation, the investigators conduct a prospective, randomized, controlled study to determine whether postoperative GnRHa (goserelin acetate) therapy for advanced endometriosis is effective in reducing endometriosis recurrence rate and improving reproductive outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Age >=18 years old
- •Normal menstruation for 3 months before enrollment (25-35 days）
- •Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia
- •Agreement on the strict follow-up plan
- •Without previous hormonal treatment
- •Using nonhormonal method of contraception during this study
排除标准
- •Serious heart diseases/pulmonary/liver/kidney diseases
- •Previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain
- •Suspected malignancy in endometriosis
- •Coagulation disorders with hemorrhagic tendency
- •Pregnancy or lactation
- •Allergy to GnRHa
- •Previous ineffective treatment with GnRHa
研究组 & 干预措施
1
Patients in this arm will be treated with goserelin depot-3.6mg plus add-back therapy.
干预措施: gonadotropin-releasing-hormone agonist (GnRHa) - Goserelin (Drug)
结局指标
主要结局
The recurrent rate of advanced endometriosis
时间窗: within one year after surgery or GnRH-a management
次要结局
- The pregnancy rate following laparoscopic surgery for advanced endometriosis(within one year after surgery or GnRH-a treatment)