2023-508896-35-00招募中4 期
Live birth after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, parallel group pragmatic trial in infertile women with at least one patent tube at Hysterosalpingo-foam sonography
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 736
- 试验地点
- 14
- 主要终点
- the occurrence of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.
研究概览
简要总结
To determine if the additional tubal flushing with oil-based contrast after undergoing Hyfosy significantly improves the occurrence rate of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy compared to no additional flushing after undergoing Hyfosy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Intervention with IMP versus control during Hyfosy
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they (1) are ≥ 18 years and < 40 years
- •(2) have infertility defined as: lack of conception despite 12 months of unprotected intercourse OR; if they are taking part in a donor sperm insemination programme: three cycles of donor insemination without pregnancy OR; in case of treated ovulation disorder: three ovulatory ovulation induction cycles without pregnancy
- •(3) have tubal patency of at least one Fallopian tube on Hyfosy
排除标准
- •known iodine allergy
- •no Belgian national number (RRN/INS)
- •allergy to poppy seed oil
- •ovulation disorders defined as less than eight menstrual cycles per year who did not have three ovulatory cycles after ovulation induction
- •contra-indication to have tubal patency testing according to the site’s indication
- •active thyroid disorders
- •untreated subclinical hypothyroidism (TSH>2.5mIU/L) in case of auto-immune thyroid disease
- •uterine surgery in the past two months before Hyfosy
- •a male partner (if applicable) with a post-wash Total Motile Sperm Count (TMC) < 1x106 and/or TMC < 3x106 in the native sperm analysis [TMC is defined as volume X concentration X (A* (progressive) + B* (non progressive) motility in %) divided by 100] OR with a history suspect of severe male factor infertility if no sperm sample is available at time of randomisation (*A+B when A,B,C is used (WHO 2010) A+B+C when A,B,C, D is used (WHO 2021))
- •an indication for IVF defined as patients who are advised to go to IVF immediately because of bilateral tubal block, severe male factor infertility, unsolved anovulatory problems, endometriosis with residual functional problems”
结局指标
主要结局
the occurrence of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.
the occurrence of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.
次要结局
未报告次要终点
研究者
Diane De Neubourg
Scientific
Antwerp University Hospital
研究点 (14)
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