Effect of Shockwaves on Fallopian Tubes Adhesion: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Assessment of Fallopian tube adhesions
研究概览
简要总结
The purpose of this study is to determine the effect of shock waves on fallopian tube adhesions.
详细描述
Tubal factor infertility accounts for approximately 40% of the cases of female infertility. Identifiable causes of tubal infertility are post-infectious tubal damage, endometriosis-related adhesions, and postsurgical adhesion formation.
Although surgical management is considered as a common choice for treating blocked tubes or adhesion it has many complications such as: infection, creation of more scar tissue, damage to organs and bleeding.
Shock waves is a modality that exerts an anti-inflammatory action and regenerative effect as well biological model. Shock waves can be nowadays considered an effective, safe, versatile, repeatable, noninvasive therapy for the treatment of many musculo-skeletal diseases, and for some pathological conditions where regenerative effects are desirable, especially when some other noninvasive/conservative therapies have failed.
For these reasons and complications of surgery, This study aims to examine the effect of shockwaves therapy on fallopian tubes adhesion
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Their ages will be ranged from 25 to 35 years old.
- •Their body mass index (BMI) will be less than 35kg/m².
- •All women will be diagnosed with fallopian tubes adhesion by the physician.
- •They have regular menstrual cycles.
- •All Patients have secondary infertility and they have previous caesarean section).
排除标准
- •Any gynecological diseases (uterine prolapse, retroversion flexion of the uterus or chronic pelvic pain).
- •Leukemia or tumor (spinal or pelvic tumor).
- •Diabetes mellitus, hypertension, heart diseases, cardiovascular diseases and skin diseases.
研究组 & 干预措施
Medical therapy group
The participants will receive medical therapy for fallopian tube adhesions as prescribed by the gynecologist
干预措施: Chitosan (Drug)
Medical therapy and Shockwave therapy group
The participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks).
干预措施: Chitosan (Drug)
Medical therapy and Shockwave therapy group
The participants will receive medical therapy plus shockwave therapy (1 session per week for 4 weeks).
干预措施: shockwave therapy (Device)
结局指标
主要结局
Assessment of Fallopian tube adhesions
时间窗: 4 weeks
Pelvic abdominal ultrasound (ultrasound scanning system, SN.w7c1882026) will be used to assess fallopian tube adhesions for all participants in both groups before and after the treatment protocol (4 weeks)
Detection of Fallopian tube patency
时间窗: 4 weeks
Hysterosalpingography (DMC GmbH, 22335 Hamburg): it is a radiologic procedure that will be used to assess fallopian tube patency ( if the fallopian tube is opened or not) for all women in both groups before and after the treatment protocol (4 weeks)
次要结局
未报告次要终点
研究者
Shorouk Fawzy Mohamed
Principle investigator
Cairo University