RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis

February 3, 2022 updated by: Song Dongmei, Fu Xing Hospital, Capital Medical University

A Prospective, Randomized,Controlled Trial on the Effect of Antibiotic Therapy on Endometrial Response in Women With Chronic Endometritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100038
        • Fuxing Hospital,Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antibiotic group
This group received antibiotic therapy
Drug: Antibiotics
Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group
Other Names:
  • Levofloxacin and Tinidazole
No Intervention: Control group
This group did not receive antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Conversion Rate of CE (From Positive to Negative)
Time Frame: 1-6 months

Subjects in antibiotic group underwent a second-look hysteroscopy and repeat endometrial biopsy for histopathological CD138 immunohistochemical examination 2-4 weeks after completion of antibiotic treatment and in the follicular phase of the following menstrual cycle. Subjects in control group underwent a second-look hysteroscopy and repeat endometrial biopsy for histopathological CD138 immunohistochemical examination ~4 weeks after recruitment in the follicular phase of the following menstrual cycle.

The biopsies were graded as "negative" for CE if there was less than one plasma cell identified per 10 high-power fields (HPFs) and "positive" when there was one or more plasma cell identified per 10 HPFs.

To compare the cure rate (From positive to negative) of CE in women who received antibiotic therapy (treatment group) with the spontaneous cure rate in those who did not receive antibiotic therapy (control group),
1-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Xing Hospital, Capital Medical University

Investigators

  • Principal Investigator: Dongmei Song, Master, Fuxing Hospital,Capital Medical University
  • Study Director: Enlan Xia, Master, Fuxing Hospital,Capital Medical University
  • Study Chair: Tinchiu Li, PhD, Fuxing Hospital,Capital Medical University
  • Study Director: Xiaoxia Peng, PhD, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2016

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FuXingH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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