Introducing intrauterine antibiotic infusion as a novel approach in effectively treating chronic endometritis and restoring reproductive dynamics: a randomized pilot study

Konstantinos Pantos, Mara Simopoulou, Evangelos Maziotis, Anna Rapani, Sokratis Grigoriadis, Petroula Tsioulou, Polina Giannelou, Nikolaos Nitsos, Panagiotis Tzonis, Michael Koutsilieris, Konstantinos Sfakianoudis, Konstantinos Pantos, Mara Simopoulou, Evangelos Maziotis, Anna Rapani, Sokratis Grigoriadis, Petroula Tsioulou, Polina Giannelou, Nikolaos Nitsos, Panagiotis Tzonis, Michael Koutsilieris, Konstantinos Sfakianoudis

Abstract

The chronic nature of Chronic Endometritis (CE) along with the challenging management and infertility entailed, call for cutting-edge therapeutic approaches. This study introduces the novel treatment of intrauterine antibiotic infusion (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization. Eighty CE patients, 40 presenting with recurrent implantation failure, and 40 with recurrent pregnancy loss, were enrolled in the IVF and the natural conception arm respectively. Treatment was subjected to randomization. Effectively treated patients proceeded with either a single IVF cycle or were invited to conceive naturally over a 6-month period. Combination of IAI and OAA provided a statistically significant enhanced effectiveness treatment rate (RR 1.40; 95%CI 1.07-1.82; p = 0.01). No statistically significant difference was observed regarding the side-effects rate (RR 1.33; 95%CI 0.80-2.22; p = 0.52). No statistically significant difference was observed for either arm regarding live-birth rate. Following an intention-to-treat analysis, employment of IAI corresponds to improved clinical pregnancy rate-albeit not reaching statistical significance. In conclusion, complimentary implementation of IAI could provide a statistically significant enhanced clinical treatment outcome.

Conflict of interest statement

The authors declare no competing interests.

© 2021. The Author(s).

Figures

Figure 1
Figure 1
CONSORT diagram presenting the progress throughout the phases entailed in this pilot study, from patients' enrollment to assessment of treatment.
Figure 2
Figure 2
Diagram presenting duration of each treatment approach employed per study group. The control group received oral antibiotic treatment for a duration of 14 days and an administration course of twice daily. Regarding the experimental group involving combined treatment of both oral and Intrauterine administration, commencement of both the oral and intrauterine administration regime was simultaneous. For the first 14 treatment days patient received both oral (twice daily) and intrauterine treatment (one infusion every three days). For the remaining 16 days the patient received only intrauterine infusions to complete the intrauterine infusion administration duration being 30 days including 10 infusions.

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