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临床试验/NCT05205993
NCT05205993招募中2 期

Investigating the Effectiveness of Innovative Intrauterine Antibiotic Therapy for the Treatment of Patients With Chronic Endometritis

Genesis Athens Clinic1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
90
试验地点
1
主要终点
Negative diagnosis of CE following hysteroscopy and endometrial biopsy

研究概览

简要总结

Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion either separately or combined with oral antibiotic administration, and it assesses respective performance against the gold standard treatment of oral antibiotic adminstration. Data sourced herein reports on treatment efficiency, defined as a negative diagnosis for chronic endometritis.

详细描述

An infectious endometrial environment caused by certain pathologies could compromise establishment of the initial interaction between the embryo and the endometrium. Chronic endometritis (CE) is a case of a persistent endometrial inflammation caused by infectious agents namely Escherichia Coli, Enterococcus faecalis, Streptococcus agalactiae, Mycoplasma, Ureaplasma, and Chlamydia. The perplexity of managing CE is attributed to its asymptomatic nature rendering a definitive diagnosis rather challenging. The list of potential symptoms is limited and vague while manifestation of the disease may be mild and may not correspond to severity. Symptoms include pain in the pelvic cavity, dispareunia, uterine bleeding, vaginal infections and cystitis, and mild gastro-intestinal discomfort. CE is described as a chronic disorder due to its long duration and persistent nature, with potentially slow progression and complex causality, severely compromising reproductive potential of patients.

The antibiotic treatments are primarily administered orally and endometrial re-examination is performed following treatment. It should be emphasized that apart from the differences in the types of antibiotics included, there are also significant discrepancies regarding the dosage of each antibiotic and the different schemes suggested by each practice. Following the antibiotic regime, endometrial receptivity is anticipated to improve. However, a significant correlation between the antibiotic therapeutic approach and a positive results in IVF has failed to be established in literature, indicating that oral antibiotic administration is unseccessful in improving IVF outcome.

A pilot study published by the investigators indicated that combination of intrauterine infusion of antibiotics and oral administration can be more effective in treating CE than solely oral administration. However, it has not been evaluated if sole intrauterine infusion of antibiotics can be of similar effectiveness when compared to the combined regime including intrauterine infusion and oral andministration, or when compared to the gold standard treatment including only oral administration of antibiotics.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Positive diagnosis of CE following hysteroscopy and endometrial biopsy (positive diagnosis is required by both evaluations)
  • Signed Informed Consent
  • 18.5 < BMI < 30

排除标准

  • Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
  • Current or previous cancer diagnosis
  • Auto-immune or genetic disorders
  • Menstrual cycle disorders

研究组 & 干预措施

Intrauterine infusion of antibiotics

Experimental

Thirty women will receive only intrauterine infusion of antibiotics for 30 days.

干预措施: Intrauterine infusion (Drug)

Combination of intrauterine infusion and oral administration of antibiotics

Experimental

Thirty women will receive a combination of intrauterine infusion and oral administration of antibiotics for 30 days.

干预措施: Intrauterine infusion (Drug)

Combination of intrauterine infusion and oral administration of antibiotics

Experimental

Thirty women will receive a combination of intrauterine infusion and oral administration of antibiotics for 30 days.

干预措施: Oral administration (Drug)

Oral administration of antibiotics

Active Comparator

Thirty women will receive only oral administration of antibiotics for 30 days.

干预措施: Oral administration (Drug)

结局指标

主要结局

Negative diagnosis of CE following hysteroscopy and endometrial biopsy

时间窗: Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-.

All participants will be subjected to hysteroscopy and endometrial biopsy following completion of treatment. Regarding hysteroscopy the presence of endometritis will be evaluated according to the published unified diagnostic criteria for CE. The endometrial biopsy will be performed employing a pipelle. To minimize contamination risk, following the placement of a vaginal speculum and cleaning external uterine ostium with an iodine solution, the pipelle will be inserted under visual control into the uterine cavity ensuring avoidance of any contact with vaginal walls. Endometrial samples will be diluted into 2 ml of saline for histological analysis. For histological analysis the endometrium samples will be fixated employing neutral formalin and paraffin. To stain the microsections, hematoxyline and eosin will be engaged. CD138 staining will be performed and positivity will indicate a CE diagnosis (\>1 plasma cell per 10HPFs). A negative CE diagnosis should be confirmed by both assessments

次要结局

  • Number of participants with treatment-related adverse events as assessed by CTCAE v6.0(Side-effects will be monitored for one month from treatment initiation which is until completion of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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