To compare the patient-reported outcomes during infertility workup after introducing an evidence-based three-dimensional/four-dimensional Hysterosalpingo-Contrast Sonography over conventional Hysterosalpingography technique: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- 1. Pain perception score in both groups using Visual Analogue Score of 0 to 10
研究概览
简要总结
This study aims to compare how patients experience two common procedures used during infertility evaluations—3D/4D Hysterosalpingo-Contrast Sonography (HyCoSy) and conventional Hysterosalpingography (HSG). These tests are used to check if the fallopian tubes are open, which is important for natural conception.
The primary objectives are:
- To compare pain levels experienced by patients during each procedure.
- To compare overall patient satisfaction with each method.
The study will take place in the outpatient department of Obstetrics and Gynaecology at AIIMS, New Delhi, after receiving approval from the Institute Ethics Committee. Eligible patients will be informed about the study and those who agree to participate will be randomly assigned to one of two groups:
- Group A: Undergoes 3D/4D HyCoSy (a newer ultrasound-based method)
- Group B: Undergoes traditional HSG (an X-ray-based method)
Procedure Details:
- In Group A (HyCoSy), patients undergo a 3D/4D ultrasound using a special contrast agent to view the uterus and fallopian tubes in real time.
- In Group B (HSG), an X-ray dye is used to visualize the same structures through radiographic images.
Pain during the procedure will be measured using a Visual Analogue Scale (VAS) from 0 to 10. Patient satisfaction will be recorded using a 5-point Likert scale.
Other information collected includes:
- Demographics, medical and reproductive history, partner details, physical exams, and routine infertility workup.
- Some patients may require further diagnostic tests like laparoscopy if results are abnormal or unclear.
- Patients with normal test results will receive standard treatment and their pregnancy outcomes will be followed up for 3 months.
By comparing patient experiences and outcomes, this study will help determine whether the newer 3D/4D HyCoSy method offers a more comfortable and satisfying alternative to the traditional HSG test during infertility evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women presented with primary or secondary infertility
- •Age between 21 to 38 years
- •Ready to provide informed written consent.
排除标准
- •Women with active genital infection including cervicitis, vaginitis and PID
- •With history of contrast allergy
- •With history of iodine allergy
- •Abnormal vaginal bleeding.
结局指标
主要结局
1. Pain perception score in both groups using Visual Analogue Score of 0 to 10
时间窗: Day 3, Day 7 and 3 months
2. Patient satisfaction in both group on a likert scale of 5 levels of satisfaction
时间窗: Day 3, Day 7 and 3 months
次要结局
- 1. Number of visits required till the procedure for tubal patency in both groups(2. Duration of the procedure starting from insertion of speculum till completion of procedure in both groups)
研究者
Dr Soniya Dhiman
AIIMS New Delhi