NCT03592849已完成不适用
The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- endometrial thickness
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients with clear fertility desires
- •Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical interventions were ineffective
- •20-42 years old
- •Normal ovarian function or with frozen embryos
- •Willing to actively cooperate with postoperative follow-up
排除标准
- •With abnormal chromosome karyotype
- •With other uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
- •Systemic diseases: hypertension, diabetes, and so on
- •Contraindications to pregnancy
- •Contraindications to hormone replacement therapy
- •Medical history of pelvic tumors or receiving pelvic radiotherapy
- •Involved in other clinical studies
- •Unable to adhere to the follow-up
结局指标
主要结局
endometrial thickness
时间窗: 12 months
endometrium thickness evaluated by transvaginal sonography during late proliferating phase
次要结局
- endometrial blood flow(6 months)
- ongoing pregnancy rate(24 months)
- live birth rate(24 months)
研究者
Yali Hu
Professor，Chief Physician of Obstetrics and Gynecology
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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