Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis

NCT05205993 | Unknown Phase 2

• 1 other identifier: IAI-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Endometritis

Outcome Measures

Primary Outcomes (1)

• Negative diagnosis of CE following hysteroscopy and endometrial biopsy

  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

  Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-.

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

  Side-effects will be monitored for one month from treatment initiation which is until completion of treatment

Study Arms (3)

Intrauterine infusion of antibiotics

EXPERIMENTAL

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

Drug: Intrauterine infusion

Combination of intrauterine infusion and oral administration of antibiotics

EXPERIMENTAL

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

Drug: Intrauterine infusion; Drug: Oral administration

Oral administration of antibiotics

ACTIVE COMPARATOR

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

Drug: Oral administration

Interventions

Intrauterine infusion 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; Intrauterine infusion of antibiotics

Oral administration 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

Combination of intrauterine infusion and oral administration of antibiotics; Oral administration of antibiotics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Genesis Athens Clinic: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Genesis AC

Athens, 15232, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 34341409 BACKGROUND

MeSH Terms

Interventions

Administration, Oral

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Konstantinos Sfakianoudis, MD

  Genesis Athens Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Sfakianoudis, MD

CONTACT

2106894326; sfakianosc@yahoo.gr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 25, 2022
• Study Start: January 19, 2021
• Primary Completion: January 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)