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临床试验/NCT03629132
NCT03629132Unknown不适用

Platelet-rich Plasma(PRP) Prevents Recurrence of Intrauterine Adhesions

Yanhong Deng0 个研究点目标入组 60 人开始时间: 2018年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
AFS score

研究概览

简要总结

Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions

详细描述

  1. Inclusion criteria: patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements.
  2. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same.
  3. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements -

排除标准

  • Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities

研究组 & 干预措施

Gel

Sham Comparator

Self-crosslinking sodium hyaluronate gel

干预措施: gel (Procedure)

PRP

Experimental

Platelet-rich plasma

干预措施: Platelet-rich plasma (Procedure)

结局指标

主要结局

AFS score

时间窗: 1 year

AFS score

次要结局

未报告次要终点

研究者

发起方
Yanhong Deng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanhong Deng

professor

Sun Yat-sen University

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