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临床试验/NCT02744807
NCT02744807已完成不适用

Prevalence of Chronic Endometritis in Severe Intrauterine Adhesions and Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 125 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
主要终点
Number of Participants With recurrence of adhesion in women with and without Chronic endometritis

研究概览

简要总结

This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.

详细描述

Chronic endometritis (CE) is a persistent in endometrium that is characterized by the presence of plasma cells. Recently, there has been increasing interest in the role of CE in recurrent pregnancy loss (RPL). One of the most common uterine abnormalities for RPL is Intrauterine adhesion (IUA).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.It is well established that the formation of IUA likely involves hypoxia, reduced neovascularization, and altered expression of adhesion-associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. It is therefore possible to hypothesize that Intrauterine adhesion may be related to chronic endometritis. To the best of researchers knowledge,there have been no reports investigating this relationship. The aim of this study was to clarify the hypothesis by evaluating the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without chronic endometritis (CE).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pre-operative adhesion score was ≥5
  • The prior menstrual cycle was regular, and the sex hormone was normal
  • with informed consent
  • absence of other uterine abnormality at transvaginal ultrasound
  • There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery.

排除标准

  • Pre-operative adhesion score was <5
  • Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
  • other uterine abnormality at transvaginal ultrasound
  • without informed consent
  • 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
  • refuse Endometrial biopsy
  • Vaginal discharge abnormal, or Suspected vaginitis or pelvic inflammatory disease, or using antibiotics.

结局指标

主要结局

Number of Participants With recurrence of adhesion in women with and without Chronic endometritis

时间窗: 1 year

Second-look hysteroscopy was carried out in the early proliferative phase, 1 to 3 months after the initial operation.After assessment of the extent and severity of any reformed adhesions, hysteroscopic adhesiolysis was also carried out at the time of the second-look procedure, if adhesions had recurred.

次要结局

  • Number of patients diagnosed with Chronic endometritis at hysteroscopy(1 year)
  • Reduction of American Fertility Society adhesion score at Second-look hysteroscopy between women with and without Chronic endometritis(1 year)
  • Number of patients with Chronic endometritis confirmed by histology(1 year)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuqing Chen

Deputy chief physician

First Affiliated Hospital, Sun Yat-Sen University

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