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
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 736
- 试验地点
- 16
- 主要终点
- Live birth
研究概览
简要总结
Ten to 15 percent of couples in their reproductive lifetime face fertility problems which is defined by WHO as the absence of pregnancy after minimal 12 months of unprotected sexual intercourse. The three most frequent causes of subfertility are: sperm defects, ovulation disorders and tubal pathology. In order to exclude tubal pathology, tubal patency tests are performed under ultrasound guidance with foam (hysterosalpingo-foam sonography (Hyfosy)) or with contrast/water (hysterosalpingo-contrast sonography (Hycosy)).
This trial will investigate whether tubal flushing with an oil-soluble contrast medium (OSCM) can increase the likelihood of a spontaneous conception after tubal patency testing with Hyfosy under ultrasound guidance compared to no additional flushing in a population of infertile women between 18 and 40 years of age with absence of pregnancy after 12 months of unprotected sexual intercourse or who have three cycles of donor insemination without pregnancy or three ovulatory ovulation induction cycles without pregnancy. The use of Lipiodol Ultra Fluide® is off-label in Hyfosy.
This multicenter, randomised, open-label, comparative and pragmatic trial compares 2 arms which will be randomised 1:1:
- Intervention group: Tubal flush with 5-10mL oil-soluble contrast medium (Lipiodol Ultra Fluide®, Guerbet, France) immediately after Hyfosy
- Control group: No additional intervention after Hyfosy The study comprises a screening period of maximum 8 weeks (w-8 to d1), randomisation (w-8 to d1), a start study visit at which the Hyfosy is performed (d1) and a fertility treatment period of 6 months (d1-w26). If the woman is not pregnant at 6 months after Hyfosy, the follow-up will last till 12 months (w52). If the participant is pregnant at 6 months after Hyfosy, the follow-up will last till maximal 4 months after live birth or miscarriage.
The primary endpoint is the occurrence of live birth, with the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy. Secondary endpoints consist of reproductive outcomes, gestational age at delivery, birth weight, neonatal mortality, major congenital anomaly, neonatal outcomes and thyroid function, pregnancy complications, number of complications during or immediately after the intervention, pain score of the Hyfosy and additional flush, thyroid function of the mother, general and disease-specific quality of life.
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
- •Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they
- •are ≥ 18 years and < 40 years
- •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
- •have tubal patency of at least one Fallopian tube on Hyfosy
排除标准
- •known iodine allergy
- •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
- •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"
- •no Belgian national number (RRN/INS)
- •A+B when A,B,C is used (WHO 2010) A+B+C when A,B,C, D is used (WHO 2021)
研究组 & 干预措施
Tubal flush with Lipiodol Ultra Fluide® after Hyfosy
干预措施: Lipiodol Ultra Fluide® (Drug)
结局指标
主要结局
Live birth
时间窗: Delivery
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
- Amount of pregnancy complications(15 months after Hyfosy)
- Number of babies(at delivery)
- Maternal thyroid function(4 weeks, 26 weeks, 15 weeks after delivery)
- Thyroid function of baby(3 days after delivery)
- Disease-specific quality of life(26 weeks)
- Number of miscarriages(15 months after Hyfosy)
- Number of ectopic pregnancies(15 months after Hyfosy)
- Number of clinical pregnancies(15 months after Hyfosy)
- Pain score of the Hyfosy with or without intervention(immediately after Hyfosy)
- Neonatal care(at delivery)
- Major Congenital Anomaly(at delivery)
- Type of pregnancy(15 months after Hyfosy)
- Complication during or after Hyfosy with intervention(immediately after intervention)
- Pain score of the intervention with IMP if applicable(immediately after intervention)
- Gestational age at delivery(at delivery)
- Birthweight(at delivery)
- General quality of life(26 weeks)
- Neonatal Mortality(at delivery)
- Gender of baby(at delivery)
研究者
Dafne Balemans
Clinical Trial Center
University Hospital, Antwerp