Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility: Complete Surgery + IVF Versus IVF (ENDOFERT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Clinical pregnancy after 2 IVF cycles
研究概览
简要总结
The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial. This study includes patients presenting colorectal DIE and infertility. Patients will be randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE prior to ART and the other group underwent ART alone (ratio 1:1)
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary and secondary infertility
- •Indication for IVF
- •Persistent pain related to endometriosis with analgesic medical treatment failure
- •Persistent pain including at least one of the following digestive symptoms related to endometriosis: Dyschesia / Sub-occlusive syndrome / Rectal bleeding / Painful defecation
- •Colorectal deep infiltrating endometriosis : Whatever lesion size / With at least rectal serosal involvement / Confirmed by MRI and 1 different investigation: vaginal ultrasound echography or coloscopic CT scan or rectal endoscope ultrasound
- •Eligible for DIE surgery
排除标准
- •Contraindication to pregnancy or to IVF
- •Viral risk
- •Previous IVF cycle(s)
- •Previous colorectal surgery
- •Need of myomectomy during surgery
- •The use of oocytes donor
研究组 & 干预措施
complete surgery
Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery
干预措施: In vitro fertilization without surgery (Procedure)
complete surgery
Prior surgery 3 months before IVF followup 1, 6 12 and 24 month after surgery
干预措施: complete surgery (Procedure)
In vitro fertilization without surgery
IVF without endometriosis surgery follow up 6, 12 and 24 month after inclusion.
干预措施: In vitro fertilization without surgery (Procedure)
结局指标
主要结局
Clinical pregnancy after 2 IVF cycles
时间窗: At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer)
Clinical pregnancy is defined as pregnancy at 6 weeks of gestation with ultrasound echographic confirmation. An IVF cycle is defined as the transfer of all the embryos created via IVF after 1 oocytes puncture until a pregnancy confirmation or until the failure of the last embryo transfer. 2 embryos are transferred for each transfer steps. The length of one cycle depend on the number of embryo transfer steps. It is usually between 2 and 9 months.
次要结局
- perioperative complications(24 months after surgery)
- Short Form (36) Health Survey _ SF 36(during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group)
- predictive factors(At the end of the 2nd IVF cycle)
- The cumulative IVF cycle cancellation rate(At the end of the 2nd IVF cycle)
- Gastrointestinal Quality of Life Index. (GIQLI)(during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group)
- Clinical pregnancy rate after 1st IVF cycle(At the end of the 1st IVF cycle (therefore at 6 weeks after each embryo transfer))
- Endometriosis Health Profile -5 (short form / EHP5)(during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group)
- Clinical pregnancy rate per embryo transferred(At the end of the 2nd IVF cycle (therefore at 6 weeks after each embryo transfer))
- The IVF complication(24 months after surgery or inclusion in "IVF without surgery" group)
- Evaluation of hemorrhagic, digestive, urinary symptoms Dysmenorrhea and pains not related to menstruation(during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group)
- Knowles Eccersley Scott Symptom (KESS) score(during inclusion, 6, 12 and 24 months after surgery or inclusion in "IVF without surgery" group)