N/A
N=120
RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis
Chronic Endometritis
Bottom Line
View on ClinicalTrials.gov: NCT02648698 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: The Conversion Rate of CE (From Positive to Negative) — 89.8; 12.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Antibiotics (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fu Xing Hospital, Capital Medical University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Conversion Rate of CE (From Positive to Negative) |
89.8; 12.7 | — |
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
Eligibility Criteria
Inclusion Criteria
- CD138 immunohistochemical staining of endometrial specimen showed presence of one or more plasma cells per 10HPF which confirmed chronic endometritis, according to published criteria.
- women who were pre-menopausal.
- no evidence of endometrial hyperplasia or malignancy or structural uterine pathology.
- agreement to have a second endometrial biopsy ~4 weeks after the initial endometrial biopsy.
- written informed consent obtained
Exclusion Criteria
- women who received steroid hormone therapy within one month of recruitment.
- allergy or suspected allergy to the chosen antibiotic therapy.
- 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.
Data sourced from ClinicalTrials.gov (NCT02648698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.