RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis
Condition: Chronic Endometritis
MeSH terms: Endometritis
Study type: Interventional

Summary: 
      120 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells
      in endometrial biopsy sample identified by immunohistochemical staining using CD138 antibody,
      have been recruited. The subjects have been randomly divided into two groups, the
      experimental group have been given antibiotic (Levofloxacin and Tinidazole for 14 days)
      treatment, the control group did not receive any antibiotic. Initially it was planned for
      women in the control group to take placebo,but the organization was difficult, so it was
      changed prior to the start of the study to an open label study. A repeat endometrial biopsy
      sample have been obtained 2-4 weeks after completion of the antibiotic therapy to assess the
      response to treatment. The conversion rate will be compared between the two groups
    

Detailed description: 
      This study will be carried out at the Hysteroscopy centre of the Fuxing Hospital, Capital
      Medical University ,Beijing, China. A total of 120 women with chronic endometritis who
      fulfilled the following inclusion criteria will be recruited:

        1. CD138 immunohistochemical staining of endometrial specimen showed presence of one or
           more plasma cells per 10HPF which confirmed chronic endometritis, according to published
           criteria.

        2. women who were pre-menopausal.

        3. no evidence of endometrial hyperplasia or malignancy or structural uterine pathology.

        4. agreement to have a second endometrial biopsy ~4 weeks after the initial endometrial
           biopsy.

        5. written informed consent obtained

      Exclusion Criteria:

        1. women who received steroid hormone therapy within one month of recruitment.

        2. allergy or suspected allergy to the chosen antibiotic therapy.

        3. women who developed any concurrent infection and received any antibiotic therapy during
           the period of study other than the one prescribed according to the study protocol.

      Power calculation: Assuming that the spontaneous CD138 conversion (from positive to negative
      ) rate is 25% and that the antibiotic therapy results in 60% conversion rate, the total
      number of subjects required in each arm of the RCT will be 37, accepting a Type I error of
      0.05 and a Type II error of 0.1, and assuming a drop-out rate of 20%, 45 subjects will need
      to be recruited into each arm. Hence, a total of 90 subjects who fulfilled the inclusion
      criteria will be required.

      Recruitment: Women have been recruited form the day case hysteroscopy unit of the
      Hysteroscopy center, Fuxing Hospital, Beijing, China. The Hysteroscopy center currently
      carries out ~600 day case hysteroscopy per month. In all cases, endometrial biopsy specimen
      will be obtained at the time of hysteroscopy for histological evaluation. Since 2013, all
      endometrial specimens have been routinely examined with the used of CD138 antibody to
      establish if there is evidence of chronic endometritis, in addition to routine
      histopathological examination. Previous audit showed that ~15% of subjects had positive
      staining for CD138 cells.We recruited the initial 132 subjects according to the inclusion and
      exclusion criteria succesfully from July 2016 to December 2018.

      Randomization:Women who had histological confirmation of CE in an endometrial biopsy specimen
      and who fulfilled the inclusion criteria were randomized into the antibiotic group and
      control group in a 1:1 ratio using a computer-generated randomization list and sealed opaque
      envelopes prepared by the first author. The patients were not blinded to the antibiotic
      treatment. The pathologist who performed the histological evaluation was blinded to the
      treatment.

      Antibiotic therapy: Women who were randomized to the treatment group were given oral
      Levofloxacin and Tinidazole daily for 14 days.

      Women who were randomized to the control group did not receive any antibiotic. Staff
      Pharmacist dispense medication.

      Consent: written informed consent will be obtained

      Repeat endometrial biopsy & histological evaluation: The repeat endometrial biopsy will be
      performed after completion of the the antibiotic therapy. Immunohistochemical study using
      CD138 antibody will be performed.
    

Intervention name(s): Antibiotics
Intervention type(s): Drug
Intervention description(s): Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group
Other intervention name(s): Levofloxacin and Tinidazole
Intervention MeSH terms: Anti-Bacterial Agents; Levofloxacin; Tinidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: chronic endometritis; CD138; antibiotic; conversion rate.