The Impact of Uterine Scratching Prior to Intra-Uterine Insemination in Unexplained Infertility, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 试验地点
- 2
- 主要终点
- Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
研究概览
简要总结
This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.
详细描述
Infertility is defined as the absence of conception after a year of unprotected intercourse. In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in unexplained infertility has been to cause a uterine trauma prior to treatment. This is done by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF and has been shown beneficial. Theoretically, the uterine scratching could increase the immune response and the vascularization of the endometrium which could help in embryo implantation. However, there is very few data concerning scratching in intrauterine insemination. The studies are mostly small studies and the results are often contradictory. In this randomized controlled trial, the investigators will evaluate the effect of uterine scratching during the follicular phase of an insemination cycle on the pregnancy rate of a large cohort of unexplained infertile couples.
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 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above.
- •At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years.
- •Antral follicular count over
- •Normal or mild male factor.
- •Normal uterine cavity.
- •An IUI prescription.
排除标准
- •Polycystic ovary syndrome with irregular menstrual cycles over 45 days
- •Severe endometriosis
- •IUI with Donor sperm
- •Patient with invasive intra-uterine procedure in the last 3 months.
- •Contraindication to endometrial biopsy.
结局指标
主要结局
Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
时间窗: 13 weeks
Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.
次要结局
- Efficacy - Secondary pregnancy rate.(6 months)
- Safety - Complications(6 months for all 3 intrauterine insemination)
- Safety - Side effects(6 months for all 3 intrauterine insemination)