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临床试验/NCT03969472
NCT03969472Unknown不适用

Effects of Probiotics and Pelvic Floor Muscle Electrophysiologic Therapy on Endometrium Repair in Patients With Intrauterine Adhesion.

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年5月5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
120
试验地点
1
主要终点
Endometrial Thickness

研究概览

简要总结

This study aimed to investigate the effects of probiotics in combination with pelvic floor muscle electrophysiologic therapy on the uterine endometrial repair and reproductive prognosis in patients after surgery for intrauterine adhesion

详细描述

Post-traumatic repair disorder of endometrium can cause intrauterine adhesions, amenorrhea and infertility, which seriously endanger women's reproductive health. In our previous study, high throughput sequencing of intrauterine microorganisms showed that the content of lactic acid bacteria in the uterine cavity of patients with intrauterine adhesions was significantly lower than that of normal people. Concurrently, our previous studies found that chronic endometritis can aggravate endometrial fibrosis, then affect the repair of endometrial trauma, and increase the recurrence of intrauterine adhesion. Our previous study also suggest that stem cells are beneficial to the repair of endometrium. Studies have shown that lactic acid can inhibit inflammatory response and regulate the proliferation of intestinal stem cells. So can lactic acid also change the microbial environment in uterine cavity to inhibit endometrial inflammation and regulate the proliferation of endometrial stem cells to help repair endometrial wounds? In addition, electrical stimulation can relieve depression and anxiety and play a sedative effect. In recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. Therefore, whether or not the pelvic floor electrophysiological therapy can repair the endometrium after the intrauterine adhesion. We expect probiotics and electrophysiologic therapy can promote endometrial repair after electrosurgical resection of intrauterine adhesions.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) Preoper- ative AFS score was ≥9; (2) the prior menstrual cycle was regular, and the sex hormone was normal; (3) patients had fertility requirement; (4) male semen examination appeared normal; (5) there were no severe systemic diseases and no contradictions to aspirin, estrogen, and surgery

排除标准

  • (1) Preoperative AFS score was <9; (2) prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction, and infertility; (3) patients had no fertility requirement; (4) patients had male factor infertility; (5) patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic anal- gesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, and gastric or duodenal ulcer and asthma

研究组 & 干预措施

probiotic group

Experimental

apply probiotic after surgery

干预措施: probiotics (Drug)

Electrophysiologic therapy group

Experimental

apply electrophysiologic therapy after surgery without probiotic

干预措施: Electrophysiologic Therapy (Device)

结局指标

主要结局

Endometrial Thickness

时间窗: Within the first 3 months after surgery

All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

次要结局

  • Menstruation Pattern of All Participants(Within the first 3 months after surgery)
  • Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants(Within the first 3 months after surgery)

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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