A Comparative Study on the Effect of Oil-based Versus Water-based Contrast Agents in Hysterosalpingography on Improving the Ongoing Pregnancy Rate in Infertile Women: a Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,187
- 试验地点
- 1
- 主要终点
- live birth
研究概览
简要总结
The goal of this clinical trial is to compare the effects of oil-based contrast medium (OBCM) and water-based contrast medium (WBCM) during hysterosalpingography（HSG）on pregnancy outcomes in infertile women. The main question it aims to answer is whether an oil-based contrast medium improves fertility outcomes in infertile women. Participants were divided into those who received an oil-based contrast medium (ethiodized poppyseed oil) and a water-based contrast medium (Ioversol) based on a shared medical decision-making process between patients and healthcare providers. The two contrast agents used in this study are routinely employed in clinical practice and will not affect the participants' health. Participants are required to complete some clinical questionnaires before and after the HSG procedure to provide clinical information. Other than that, there will be no additional costs for participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •infertility for at least one year without the use of contraceptives.
排除标准
- •endocrine disorders, including Cushing's syndrome, hypothalamic amenorrhea, adrenal hyperplasia, diabetes, or thyroid dysfunction (except for well-controlled hypothyroidism with a TSH level between 0.3 and 4.0 mIU/L)
- •known allergy to contrast agents, specifically iodine
- •male partner infertility, defined as post-wash sperm motility <3 million/mL or <1 million/mL without sperm washing
- •contraindications for undergoing HSG
- •refusal to provide informed consent.
研究组 & 干预措施
oil-based contrast medium
oil-based contrast medium: ethiodized poppyseed oil (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 480 mg/ml)
干预措施: oil-based contrast medium (Drug)
warer-based contrast medium
water-based contrast medium: Ioversol (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, Jiangsu Province, China, H20067895, iodine concentration of 320 mg/ml)
干预措施: water-based contrast medium (Drug)
结局指标
主要结局
live birth
时间窗: From enrollment to the end of treatment at 6 months
The primary outcome measure is live birth from pregnancies occurring within 6 months after HSG, defined as a live birth after 24 weeks of gestation, with the last menstrual period starting within six months post-HSG.
次要结局
- clinical pregnancy(From enrollment to the end of treatment at 6 months)
- ongoing pregnancy(From enrollment to the end of treatment at 6 months)
- miscarriage(From enrollment to the end of treatment at 6 months)
- ectopic pregnancy(From enrollment to the end of treatment at 6 months)