Diagnostics of Chronic Endometritis in Infertility

NCT ID: NCT05946655

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-10-30

Brief Summary

Chronic endometritis (CE) is characterized by the presence of atypical plasma cell infiltrates (CD138 positive) in the endometrial stroma. Recent analyzes suggest that CE adversely affects fertility by reducing endometrial receptivity, impairing decidualization and uterine contractility, thus increasing the risk of recurrent pregnancy loss and implantation failure. It is likely that a significant proportion of idiopathic infertility cases are due to CE. The diagnosis of CE is a challenge because the clinical examination and transvaginal ultrasonography are considered non-specific. The recent scientific research has been aimed at identifying hysteroscopic CE diagnostic criteria and establishing the compatibility of ultrasonographic, hysteroscopic, histopathological (including the use of immunohistochemical testing with antibodies against human CD138) and microbiological diagnoses. Preliminary literature results suggested that successful treatment of CE with antibiotics could improve live birth rates.

Detailed Description

The objectives are as follows:

1. Estimation of the diagnostic congruity of hysteroscopic, histopathological and microbiological diagnoses of CE

2. Estimation of the effectiveness of empirical antibiotic therapy in the treatment of CE, confirmed by normalization of the hysteroscopic appearance of the uterine cavity, normalization of histopathological results of endometrial biopsies and decrease in plasma cell count/1 high power field (HPF)

3. Estimation of the percentage of clinical pregnancies achieved in women subjected to empiric antibiotic therapy for CE vs. in women without treatment. The study group will consist of women of childbearing age subjected to office hysteroscopy due to intrauterine pathologies, AUB, and idiopathic infertility. The prerequisite for hysteroscopy is a normal cervical cytology result, a negative blood pregnancy test, a normal vaginal biocenosis and the first phase of the cycle. During hysteroscopy, the following will be performed: visual inspection of the uterine cavity in search of focal lesions and features of the endometrium suggestive of CE, such as: focal or diffuse hyperemia, micropolyps, stromal edema, then collection of washings from the uterine cavity for microbiological examination (aerobic and anaerobic culture, PCR for Chlamydia, culture for Mycoplasma, Ureaplsma) and excision of the focal lesion or endometrial biopsy. The extracted tissue material will be subjected to standard histopathological examination with hematoxylin and eosin staining. Additional immunohistochemical staining with Monoclonal Mouse Anti-Human CD138 antibodies will be used to detect plasmocytes. The cut-off point for the number of CE-defining plasmocytes will be determined by the Receiver Operating Characteristic (ROC) curve. Women diagnosed with CE will be assigned to 2 arms: 1) ofloxacin 2x200 mg orally for 10 days + metronidazole 1x500 mg vaginally for 10 days, 2) control arm (no treatment). In the third cycle after the primary hysteroscopy, women will undergo a follow-up office hysteroscopy for a visual assessment of the uterine cavity and a follow-up endometrial biopsy. The percentage of women with improvement in the clinical appearance of the uterine cavity, normalization of histopathology and persistent CE in both arms will be determined. Data will be obtained on the results of infertility treatment (obtaining a clinical pregnancy) within 24 months of the procedure or completion of antibiotic therapy.

Conditions

Infertility Unexplained; Abnormal Uterine Bleeding; Intrauterine Disorder

Study Design

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

Study Groups

Antibiotic therapy

Women diagnosed with CE undergoing empirical antibiotic therapy

Group Type: EXPERIMENTAL

Ofloxacin + Metronidazole

Intervention Type: DRUG

Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days

Control

Women diagnosed with CE not subjected to empirical antibiotic therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ofloxacin + Metronidazole

Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 18-45 years
• lack of previous diagnosis and treatment due to suspected pathology of the uterine cavity
• lack of active infection of the reproductive tract

Exclusion Criteria

• pelvic surgery performed within 6 months preceding the hysteroscopy
• confirmed pelvic endometriosis
• antibiotic or probiotic treatment within 3 months preceding the hysteroscopy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Iwona Magdalena Gawron

M.D., Ph.D., Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Jach, Prof., PhD

Role: STUDY_CHAIR

Jagiellonian University

Locations

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, Malopolska, Poland

Countries

Poland

Other Identifiers

1072.6120.322.2020

Identifier Type: -

Identifier Source: org_study_id