Effects of Aspirin and Intrauterine Balloon on the Post-operative Uterine Endometrial Repair and Reproductive Prognosis in Patients With Severe Intrauterine Adhesion: 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
- 114
- 试验地点
- 1
- 主要终点
- Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
研究概览
简要总结
This study aimed To investigate the effects of estrogen in combination with aspirin and intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients after surgery for severe intrauterine adhesion .
详细描述
This cohort study was conducted to investigate whether aspirin could promote the endometrial growth and repair, reduce the recurrence of intrauterine adhesion and improve the menstruation and reproductive prognosis after surgery for severe intrauterine adhesion. Menstruation was evaluated for the first time with a method similar to visual analogue scale (VAS) in which the menstruation was assessed by the patients themselves with 0 as amenorrhea and 100 as normal menstruation. This evaluation avoids the vague terms (such as large or small menstrual blood volume) in previous evaluations and considers the individual difference in menstrual blood volume and different understanding about the menstrual blood volume. Thus, this evaluation is easy to master, quantify and analyze.
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
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-operative adhesion score was ≥9
- •The prior menstrual cycle was regular, and the sex hormone was normal
- •Patients had fertility requirement
- •Male semen examination showed normal; (5) There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery
排除标准
- •Pre-operative adhesion score was <9
- •Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
- •Patients had no fertility requirement
- •Patients had male factor infertility
- •Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma.
研究组 & 干预措施
non-balloon group
with aspirin
干预措施: Aspirin (Drug)
balloon group
with aspirin and intrauterine balloon
干预措施: Aspirin (Drug)
balloon group
with aspirin and intrauterine balloon
干预措施: intrauterine balloon (Device)
结局指标
主要结局
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
时间窗: Within the first 3 months after surgery
次要结局
- Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants(Within the first 3 months after surgery)
- Number of Participants With Pregnancy after operation(three years)
- Menstruation Pattern(Improvement or No Significant Change) of All Participants(Within the first 3 months after surgery)
研究者
Yuqing Chen
Deputy chief physician
First Affiliated Hospital, Sun Yat-Sen University