Tubal Flushing With Oil-based Contrast During HSG in Subfertile Women: Is Early Flushing Effective and Cost-effective as Compared to Delayed Flushing? - H2Oil-timing Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Time to live birth
研究概览
简要总结
The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
详细描述
Rationale: The investigators hypothesize that direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology, which will lead to a reduction in the need for expensive fertility treatments like IVF and/or ICSI, and will therefore be an effective and cost effective strategy.
Objective: The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
Study design: The investigators plan a multicentre randomized controlled trial with an economic analysis alongside it. Infertile women at low risk for tubal pathology will be randomized to direct tubal flushing with oil-based contrast incorporated in the fertility work-up or delayed tubal flushing 6 months after fertility work-up is completed.
Study population: Infertile women 18-38 years of age, who have a spontaneous menstrual cycle and at low risk for tubal pathology, undergoing fertility work-up.
Intervention (if applicable): Direct tubal flushing with oil-based contrast at HSG as part of the fertility work-up compared to delayed tubal flushing 6 months after the fertility work-up is completed.
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
- •Women between 18-39 years of age
- •Spontaneous menstrual cycle
- •Perceived low risk for tubal pathology
- •Undergoing fertility work-up
排除标准
- •Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
- •Ovulation disorders defined as less than eight menstrual cycles per year
- •Iodine allergy
- •Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml
- •Not willing or able to sign the consent form
研究组 & 干预措施
Direct HSG during fertility work-up
Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up
干预措施: Lipiodol UltraFluid (Drug)
Delayed HSG 6 months after completing fertility work-up
Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up
干预措施: Lipiodol UltraFluid (Drug)
结局指标
主要结局
Time to live birth
时间窗: 12 months
Calculated from the last menstrual bleeding within 12 months after randomization
次要结局
- Number of clinical pregnancies(12 months)
- Number of miscarriages(12 months)
- Number of ectopic pregnancies(12 months)
- Number of live births(12 months)
- Number of ongoing pregnancies(6 months)
- Incidence of thyroid dysfunction after HSG(One month after HSG)
- Number of cycles of artificial reproductive techniques(12 months)
- Number of multiple pregnancies(12 months)
- Number of pregnancy complications(12 months)
- Neonatal thyroid dysfunction(Within one week after birth)
- Number of complication after HSG(One month after HSG)
- Number of still births(6 months)
研究者
Prof. Velja Mijatovic
Professor
Amsterdam UMC, location VUmc