Dongmei Song, M.D., Yanfei He, M.B.B.S., Yixuan Wang, B.S., Ziyu Liu, M.Med., Enlan Xia, M.B.B.S., Xiaowu Huang, Ph..D., Yu Xiao, Ph.D., Tin-Chiu Li, Ph.D.
To compare the rates of negative test results for chronic endometritis (CE) between subjects who did and did not receive antibiotic treatment.
Prospective, single-blind randomized controlled trial.
Tertiary hysteroscopic center in a university teaching hospital.
A total of 132 women with CE confirmed with immunohistochemical study with CD138 epitope.
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).
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%).
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