Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 主要终点
- Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
研究概览
简要总结
The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility.
详细描述
Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health. Currently, hysteroscopy is the preferred method of intrauterine adhesions diagnosis and treatment. However, because intrauterine adhesions patients generally have poor endometrium repair capability, the incidence rate of reformation of intrauterine adhesions ranging from 20%-62.5% in those with severe adhesions. The successful pregnancy rate after treatment in severe Asherman's syndrome is reported to be consistently lower, only 33%. The prevention of intrauterine adhesions recurrence after trans-cervical resection of adhesion is clinically important but difficult. Therefore, this study was conducted.
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 (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of severe intrauterine adhesions
- •infertility
排除标准
- •endometrial tuberculosis
- •grossly abnormal semen analysis
- •ovarian failure, hydrosalpinx fluid
- •patients who did not proceed to second-look hysteroscopy within the specified time frame
- •Women with no desire to pregnancy
结局指标
主要结局
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
时间窗: three years
次要结局
- Menstruation Pattern(Improvement or No Significant Change) of All Participants(Within the first 3 months after surgery)
- Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group(Within the first 3 months after surgery)
- Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound(Within the first 3 months after surgery)
研究者
Yuqing Chen
Associate chief physician
First Affiliated Hospital, Sun Yat-Sen University
