Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis

Genesis Athens Clinic

Status and phase: Enrolling; Phase 2

Conditions: Chronic Endometritis

Treatments: Drug: Oral administration; Drug: Intrauterine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05205993

IAI-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Intrauterine infusion of antibiotics

Experimental group

Description:

Thirty women will receive only intrauterine infusion of antibiotics for 30 days.

Treatment:

Drug: Intrauterine infusion

Combination of intrauterine infusion and oral administration of antibiotics

Experimental group

Description:

Thirty women will receive a combination of intrauterine infusion and oral administration of antibiotics for 30 days.

Treatment:

Drug: Oral administration

Drug: Intrauterine infusion

Oral administration of antibiotics

Active Comparator group

Description:

Thirty women will receive only oral administration of antibiotics for 30 days.

Treatment:

Drug: Oral administration