Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05205993
Study type Interventional
Source Genesis Athens Clinic
Contact Konstantinos Sfakianoudis, MD
Phone 2106894326
Status Recruiting
Phase Phase 2
Start date January 19, 2021
Completion date April 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT04432467 - Fertility Restoration Using Autologous Mesenchymal Stem Cells Phase 1/Phase 2
Completed NCT02744807 - Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions N/A
Completed NCT02646930 - Chronic Endometritis and IVF N/A
Completed NCT04447625 - Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics Phase 2
Completed NCT02680275 - Efficacy of Dead Sea Peloid Gel in Chronic Endometritis N/A
Completed NCT02648698 - RCT(Randomized Clinical Trial ) of Antibiotic Therapy in Chronic Endometritis N/A
Terminated NCT03169621 - Diagnosis of Chronic Endometritis in Endometrial Fluid Using Molecular Techniques to Improve the Outcomes of Assisted Reproductive Treatments