跳至主要内容
临床试验/NCT03731689
NCT03731689Unknown不适用

Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

研究概览

简要总结

This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.

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.It is well established that the formation of intrauterine adhesion 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. Intrauterine adhesion separation surgery is the gold standard for the treatment of uterine adhesion. Although the success rate is as high as 95%, the patients with moderate or severe uterine adhesion have severe damage to the endometrial basement, poor regeneration of endometrial and gland, poor tolerance of endometrial and poor clinical prognosis. Even if all kinds of anti-adhesion measures are used comprehensively, the postoperative recurrence rate of patients with moderate and severe uterine adhesion is high.Therefore this study was conducted to investigate whether intrauterine lavage or intrauterine gel-injection therapy after surgery could reduce the recurrence of intrauterine adhesion, promote the endometrial growth and repair and improve the menstruation and reproductive prognosis for severe intrauterine adhesion, and we hypothesize that intrauterine adhesion may be related to changes in microbial flora in the reproductive tract.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria(experimental group and control group):
  • Pre-operative adhesion score was ≥5
  • The prior menstrual cycle was regular, and the sex hormone was normal
  • Patients had fertility requirement
  • Male semen examination showed normal
  • There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery
  • Inclusion Criteria(healthy control group):
  • regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity
  • the healthy women recruited had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.

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
  • Patients had no fertility requirement
  • Patients(experimental group and control group) had male factor infertility
  • 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.

研究组 & 干预措施

Intrauterine lavage therapy group

Experimental

Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.

干预措施: Intrauterine lavage therapy (Drug)

Intrauterine gel-injection therapy group

Experimental

Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery.

干预措施: Intrauterine gel-injection therapy (Drug)

结局指标

主要结局

Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

时间窗: 1 year

次要结局

  • Menstruation Pattern(Improvement or No Significant Change) of All Participants(1 year)
  • Reduction of American Fertility Society adhesion score at Second-look(one year)
  • Number of Participants With Pregnancy after operation(two years)
  • Differences in distribution of reproductive tract bacteria between patients are before and after operation(one year)
  • Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients(one 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

chief physician

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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