Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Cumulative pregnancy rate (CPR)
研究概览
简要总结
The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.
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
- •Rectosigmoid endometriosis and wish for surgery
- •Pregnancy intention for at least 6 months
- •AMH above 5 pmol/ml
- •Maximum of 2 previous IVF treatments
- •Male partner
排除标准
- •Endometriosis involving the ureter unilaterally or bilaterally (randomization unethical)
- •BMI above 32
- •Contraindication for IVF (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions)
- •No wish for randomization
研究组 & 干预措施
Operation
Operation for severe endometriosis
干预措施: Operation (Procedure)
Fertility treatment
Fertility treatment for women with severe endometriosis.
干预措施: Fertility treatment (Procedure)
结局指标
主要结局
Cumulative pregnancy rate (CPR)
时间窗: 18 months
Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8
Live birth rate (LBR)
时间窗: 18 months
Rate of live births
次要结局
- Quality of Life (QoL)(Baseline, 9 and 18 months)
- Endometriosis hormonal and inflammatory status(Baseline and 9-18 months)
- Non-viable pregnancies(18 months)
- Fertility treatment complications(18 months)
- Pain score(Baseline, 9 and 18 months)
- Delayed bowel function(Baseline, 9 and 18 months)
- Blastocyst morphology score(18 months)
- Ovarian potential(Baseline and 9-18 months)
- Time to pregnancy(18 months)
- Postoperative complications(18 months)
- Delayed bladder function(Baseline, 9 and 18 months)
- Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos(18 months)
研究者
Ulla Breth Knudsen
Professor
Horsens Hospital