IVF Versus Surgery for the Treatment of Infertility Associated to Ovarian and Deep Peritoneal Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 6
- 主要终点
- Live birth rate from pregnancies started within 12 months since randomization
研究概览
简要总结
The management of endometriosis-related infertility remains controversial. In particular, there is an equipoise for infertile women with endometriotic lesions detected at ultrasound. These women can be managed with either surgery or in vitro fertilization (IVF). The two approaches radically differ and they have never been compared with a randomized trial. As a consequence, affected women currently receive contrasting information and the mode of treatment substantially differ among centres, reflecting the local expertise of physicians rather than clinical needs.
The present study aims at clarify whether IVF could be superior to surgery in infertile women with endometriotic lesions detected at ultrasound. This topic will be addressed comparing the two approaches in terms of effectiveness and cost-effectiveness. In addition, the study will disentangling whether the endometriosis-related systemic inflammatory mechanisms may have an impact on the quality of folliculogenesis and on IVF outcomes. This specific objective will be pursued through the characterization and analysis of circulating extracellular vesicles (EV)-immunologic, proteomic and miRNA signatures and measurement of steroid hormones in follicular fluid.
详细描述
Women accepting to enter the study will be randomized to either surgery and then natural pregnancy seeking or a program of three complete IVF cycles (i.e. three oocytes retrievals regardless of the number of embryo transfers performed). The initial time point will be the time of randomization. Women of both study groups will initiate treatment (surgery or IVF) in a shortest delay, maximum 3 months. Only live birth pregnancies and initiating within a 12-months period starting from this time point will be included in the primary outcome.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age < 40 years
- •Pregnancy seeking for more than 12 months
- •Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days
- •Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.
- •Normal seminal analysis based on WHO criteria
- •Absence of ureteral stenosis or intestinal subocclusive symptoms
排除标准
- •Previous surgery for endometriosis
- •Previous IVF cycles
- •Contraindication to pregnancy
- •Hydrosalpinx
- •Endometriomas with a mean diameter > 4 cm
- •Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
- •Doubtful sonographic findings that do not allow to reliably rule out malignancy.
- •Obstacles to regular sexual intercourses (sexual disturbances or logistic problems)
结局指标
主要结局
Live birth rate from pregnancies started within 12 months since randomization
时间窗: up to 12 months since randomization
to assess whether IVF is more effective than surgery in obtaining a live birth and, if so, what is the magnitude of this benefit
次要结局
- Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV).(3 months)
- Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis(12 months)