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Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05205993
Recruitment Status : Recruiting
First Posted : January 25, 2022
Last Update Posted : February 24, 2023
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Genesis Athens Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Endometritis Drug: Intrauterine infusion Drug: Oral administration Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effectiveness of Innovative Intrauterine Antibiotic Therapy for the Treatment of Patients With Chronic Endometritis
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intrauterine infusion of antibiotics
Thirty women will receive only intrauterine infusion of antibiotics for 30 days.
 Drug: Intrauterine infusion
A total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
Experimental: 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.
 Drug: Intrauterine infusion
A total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

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
Active Comparator: Oral administration of antibiotics
Thirty women will receive only oral administration of antibiotics for 30 days.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Negative diagnosis of CE following hysteroscopy and endometrial biopsy [ Time Frame: Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-. ]
    All participants will be subjected to hysteroscopy and endometrial biopsy following completion of treatment. Regarding hysteroscopy the presence of endometritis will be evaluated according to the published unified diagnostic criteria for CE. The endometrial biopsy will be performed employing a pipelle. To minimize contamination risk, following the placement of a vaginal speculum and cleaning external uterine ostium with an iodine solution, the pipelle will be inserted under visual control into the uterine cavity ensuring avoidance of any contact with vaginal walls. Endometrial samples will be diluted into 2 ml of saline for histological analysis. For histological analysis the endometrium samples will be fixated employing neutral formalin and paraffin. To stain the microsections, hematoxyline and eosin will be engaged. CD138 staining will be performed and positivity will indicate a CE diagnosis (>1 plasma cell per 10HPFs). A negative CE diagnosis should be confirmed by both assessments


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 [ Time Frame: Side-effects will be monitored for one month from treatment initiation which is until completion of treatment ]
    Number of reports of side-effects according to CTCAE v6.0 per treated patients


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05205993


Contacts
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Contact: Konstantinos Sfakianoudis, MD 2106894326 sfakianosc@yahoo.gr

Locations
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Greece
Genesis AC Recruiting
Athens, Greece, 15232
Contact: Panagiotis Tzonis, MD    6937115569    ptzonis@gmail.com   
Sponsors and Collaborators
Genesis Athens Clinic
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Konstantinos Sfakianoudis, MD Genesis Athens Clinic
More Information
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Publications:

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Responsible Party: Genesis Athens Clinic
ClinicalTrials.gov Identifier: NCT05205993    
Other Study ID Numbers: IAI-1
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Uterine Diseases
Genital Diseases