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

NCT02648698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-02-07

Study results available
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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

Conditions

  • Chronic Endometritis

Interventions

DRUG

Antibiotics

Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group

Sponsors & Collaborators

  • Fu Xing Hospital, Capital Medical University

    lead OTHER

Principal Investigators

  • Dongmei Song, Master · FuXing Hospital,Capital Medical University

  • Enlan Xia, Master · FuXing Hospital,Capital Medical University

  • Tinchiu Li, PhD · FuXing Hospital,Capital Medical University

  • Xiaoxia Peng, PhD · Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-10
Primary Completion
2018-12-15
Completion
2018-12-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648698 on ClinicalTrials.gov