Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis

NCT ID: NCT05205993

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2024-04-30

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.

Conditions

Chronic Endometritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intrauterine infusion of antibiotics

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

Group Type: EXPERIMENTAL

Intrauterine infusion

Intervention Type: DRUG

A total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

Combination of intrauterine infusion and oral administration of antibiotics

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

Group Type: EXPERIMENTAL

Intrauterine infusion

Intervention Type: DRUG

A total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

Oral administration

Intervention Type: DRUG

per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day and metronidazole of 500mg twice a day for a total of 30 days

Oral administration of antibiotics

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

Group Type: ACTIVE_COMPARATOR

Oral administration

Intervention Type: DRUG

per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day and metronidazole of 500mg twice a day for a total of 30 days

Interventions

Intrauterine infusion

A total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

Intervention Type: DRUG

Oral administration

per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day and metronidazole of 500mg twice a day for a total of 30 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

Genesis Athens Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konstantinos Sfakianoudis, MD

Role: PRINCIPAL_INVESTIGATOR

Genesis Athens Clinic

Locations

Genesis AC

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Konstantinos Sfakianoudis, MD

Role: CONTACT

sfakianosc@yahoo.gr

2106894326

Facility Contacts

Panagiotis Tzonis, MD

Role: primary

ptzonis@gmail.com

6937115569

References

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.

Reference Type: BACKGROUND

PMID: 34341409 (View on PubMed)

Other Identifiers

IAI-1

Identifier Type: -

Identifier Source: org_study_id