Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Treatment efficiency rate
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 (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Positive diagnosis of CE
- •Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF)
- •No previous live birth
- •FSH and LH levels -evaluated on day 2 of the menstrual cycle- <12 IU/ml
- •AMH levels >1.1ng/ml
- •Progesterone levels -evaluated on day 21 of the menstrual cycle- > 2 and <25 ng/ml
- •18.5<BMI<29.9
- •18<Patients' age<40
排除标准
- •Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
- •Current or previous cancer diagnosis
- •Auto-immune, genetic or reproductive disorders
- •Reproductive history of pregnancy loss due to genetic abnormalities
- •Male factor infertility diagnosis
研究组 & 干预措施
CE patients receiving OAA
Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)
干预措施: Oral antibiotic administration (Drug)
CE patients receiving OAA and IAI
Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)
干预措施: Oral antibiotic administration (Drug)
CE patients receiving OAA and IAI
Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)
干预措施: Intrauterine antibiotic infusion (Drug)
结局指标
主要结局
Treatment efficiency rate
时间窗: Treatment efficiency rate was assessed immediately after treatment completion
Negative results in all three diagnostic evaluations of CE namely hysteroscopic investigation, endometrial biopsy, along with histological analysis and microbiological culture indicating successful treatment of CE
Side-effects rate
时间窗: Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2
Number of reports of minimal, mild, and moderate side-effects per treated patients
次要结局
- Live birth rate(A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.)
- Clinical pregnancy rate(Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.)