Clinical trial NCT05205993: Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis
Official title: Investigating the Effectiveness of Innovative Intrauterine Antibiotic Therapy for the Treatment of Patients With Chronic Endometritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Endometritis
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2022-01-25
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion either separately or combined with oral antibiotic administration, and it assesses respective performance against the gold standard treatment of oral antibiotic adminstration. Data sourced herein reports on treatment efficiency, defined as a negative diagnosis for chronic endometritis.

Detailed description: An infectious endometrial environment caused by certain pathologies could compromise establishment of the initial interaction between the embryo and the endometrium. Chronic endometritis (CE) is a case of a persistent endometrial inflammation caused by infectious agents namely Escherichia Coli, Enterococcus faecalis, Streptococcus agalactiae, Mycoplasma, Ureaplasma, and Chlamydia. The perplexity of managing CE is attributed to its asymptomatic nature rendering a definitive diagnosis rather challenging. The list of potential symptoms is limited and vague while manifestation of the disease may be mild and may not correspond to severity. Symptoms include pain in the pelvic cavity, dispareunia, uterine bleeding, vaginal infections and cystitis, and mild gastro-intestinal discomfort. CE is described as a chronic disorder due to its long duration and persistent nature, with potentially slow progression and complex causality, severely compromising reproductive potential of patients.

The antibiotic treatments are primarily administered orally and endometrial re-examination is performed following treatment. It should be emphasized that apart from the differences in the types of antibiotics included, there are also significant discrepancies regarding the dosage of each antibiotic and the different schemes suggested by each practice. Following the antibiotic regime, endometrial receptivity is anticipated to improve. However, a significant correlation between the antibiotic therapeutic approach and a positive results in IVF has failed to be established in literature, indicating that oral antibiotic administration is unseccessful in improving IVF outcome.

A pilot study published by the investigators indicated that combination of intrauterine infusion of antibiotics and oral administration can be more effective in treating CE than solely oral administration. However, it has not been evaluated if sole intrauterine infusion of antibiotics can be of similar effectiveness when compared to the combined regime including intrauterine infusion and oral andministration, or when compared to the gold standard treatment including only oral administration of antibiotics.

Eligibility criteria: Inclusion Criteria:

* Positive diagnosis of CE following hysteroscopy and endometrial biopsy (positive diagnosis is required by both evaluations)
* Signed Informed Consent
* 18.5 \< BMI \< 30

Exclusion Criteria:

* Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
* Current or previous cancer diagnosis
* Auto-immune or genetic disorders
* Menstrual cycle disorders

Primary outcomes:
measure: Negative diagnosis of CE following hysteroscopy and endometrial biopsy
timeFrame: Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-.
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
timeFrame: Side-effects will be monitored for one month from treatment initiation which is until completion of treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Genesis AC
Study officials:
affiliation: Genesis Athens Clinic
name: Konstantinos Sfakianoudis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pantos K, Simopoulou M, Maziotis E, Rapani A, Grigoriadis S, Tsioulou P, Giannelou P, Nitsos N, Tzonis P, Koutsilieris M, Sfakianoudis K. Introducing intrauterine antibiotic infusion as a novel approach in effectively treating chronic endometritis and restoring reproductive dynamics: a randomized pilot study. Sci Rep. 2021 Aug 2;11(1):15581. doi: 10.1038/s41598-021-95072-w.