Impact of antibiotic therapy on the rate of negative test results for chronic endometritis: a prospective randomized control trial

Abstract

Objective: To compare the rates of negative test results for chronic endometritis (CE) between subjects who did and did not receive antibiotic treatment.

Design: Prospective, single-blind randomized controlled trial.

Setting: Tertiary hysteroscopic center in a university teaching hospital.

Patient(s): A total of 132 women with CE confirmed with immunohistochemical study with CD138 epitope.

Intervention(s): Women randomized to antibiotic therapy received oral levofloxacin 500 mg and tinidazole 1,000 mg daily for 14 days. Women randomized to the control group did not receive any treatment. A repeated endometrial biopsy was performed 4 to 8 weeks after the initial biopsy to determine whether CE was still present.

Main outcome measure(s): The rate of negative test results for CE (from positive to negative).

Result(s): The CE rate of negative test results in the treatment group (89.3%) after one course of antibiotic treatment was significantly higher than that in the control group (12.7%). Among subjects who attempted pregnancy, there was no significant difference in ongoing pregnancy rates and miscarriage rates between the treatment arm (43.2%, 5.4%) and the control arm (25.7%, 14.3%). Among subjects randomized, there was also no significant difference in ongoing pregnancy rates and miscarriage rates between the treatment arm (27.1%, 3.4%) and the control arm (16.4%, 9.1%).

Conclusion: A course of broad-spectrum oral antibiotic therapy for 14 days is effective in the treatment of CE in >89.8% of cases. However, it is not yet clear whether treatment improved pregnancy outcomes.

Clinical trial identification number: NCT02648698.

Keywords: Antibiotic; CD138; chronic endometritis; rate of negative test results.