Therapeutic Endometrial Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Rate of clinical pregnancy
研究概览
简要总结
The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth.
Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.
详细描述
Randomized controlled prospective clinical study.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment
- •Planned Antagonist treatment
- •Planned Standardized hormone treatment
- •FSH: 2-12 IU/L
- •Age: 18-40 years
- •BMI: 18-32
- •Regular menstrual cycles
- •Written consent
排除标准
- •Patients in need for a interpreter
- •Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges)
- •Planned use og Assisted hatching or use of specialized media
- •Previous inclusion in the study
研究组 & 干预措施
Intervention
Endometrial biopsy before standard treatment
干预措施: Endometrial biopsy (Other)
Control
Standard treatment
结局指标
主要结局
Rate of clinical pregnancy
时间窗: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.
次要结局
- Rate of biochemical pregnancy(Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years.)
- Rate of implantation(Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.)
- Rate of live birth(Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years.)