A Multi-center, Randomized, Single-blind, Controlled Clinical Trial of Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter balloon.
详细描述
Severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. In order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. However, they don't improve the microenvironment of endometrial regeneration. It's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. This study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than Foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. In addition, the study will be carried out in 2 centers, one is the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, the other is Changzhou Maternal and Child Health Care Hospital that is in Jiangsu Province.
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
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having a clear desire to fertility;
- •Infertility that is defined as a women fails to become pregnant after having a normal sex life for two years without contraception.
- •Hysteroscopy examination confirmed intrauterine adhesions(patients who has at least one of the three symptoms which are amenorrhea, hypomenorrhea or infertility, and hysteroscopy or histologic diagnosis of intrauterine adhesions), meeting American Fertility Society diagnostic criteria Ⅱ-III;
- •Normal ovarian function;
- •Regular Menstrual cycles and menstruation is normal before abortion or curettage;
- •BMI< 30 kg/m2;
- •Sign a consent form;
- •Follow the test plan and follow-up process.
排除标准
- •Hereditary diseases;
- •Simple thin endometrium with no uterine cavity adhesion;
- •Simple Uterine scar formation with no uterine cavity adhesion after hysteroscopic adhesiolysis;
- •Contraindications to bone marrow collection or assisted reproductive technology;
- •History of malignant tumor;
- •Other diseases associated with the uterus: uterine fibroids, severe adenomyosis, severe malformations of the uterus;
- •Abnormal blood coagulation, liver and kidney dysfunction, or other diseases which the researchers think may affect the study(such as: uncontrolled hypertension, diabetes, sexually transmitted diseases);
- •With a positive urine pregnancy test；
- •Participating in other clinical studies at the same time;
- •Hysteroscopic adhesiolysis more than 3 times in the past.
结局指标
主要结局
Ongoing pregnancy rate
时间窗: up to 24 months
A successful clinical pregnancy means that at the 12th week of pregnancy, ultrasound reveals that the fetus had a heart activity and the size of the fetus is in consistent with the gestational week.
次要结局
- ectopic pregnancy rate(up to 24 months)
- live birth rate(up to 24 months)
- Miscarriage rate(up to 24 months)
- Maximal endometrial thickness(at 3 and 6 months post-operation)
- Re-adhesion rate at the second-look hysteroscopy(at 3 months post-operation)
- preterm birth rate(up to 24 months)
- Menstrual volumes and menstrual improvement:(at 3 and 6 months post-operation)
- AFS score at the second-look hysteroscopy and AFS score decrease compared to pre-operation(at 3 months post-operation)
研究者
Yali Hu
MD,PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School