Overview

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

Status:
Completed

Trial end date:
2018-12-15

Target enrollment:
0

Participant gender:
Female

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

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fu Xing Hospital, Capital Medical University

Treatments:

Anti-Bacterial Agents
Antibiotics, Antitubercular
Levofloxacin
Ofloxacin
Tinidazole
Vitamins

Criteria

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.