An observational study in Endometritis, Infertility and Hysteroscopy, sponsored by Faculty Hospital Kralovske Vinohrady. Recruiting at 2 sites in Czechia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Faculty Hospital Kralovske Vinohrady · Observational
Chronic endometritis (CE) is a long-lasting inflammation of the lining of the uterus. Many women with CE do not have symptoms, but the condition may affect fertility, embryo implantation, and pregnancy outcomes. CE is usually diagnosed during hysteroscopy, a procedure that allows doctors to look inside the uterus and collect a small tissue sample for laboratory testing.
The goal of this prospective cohort study is to learn how common CE is in women with infertility and to determine whether antibiotic treatment improves reproductive outcomes. The study will also examine whether hysteroscopic findings match laboratory-confirmed CE and whether certain findings can help doctors diagnose CE more accurately. In addition, researchers will study the types of bacteria found in the uterine lining and their possible relationship to fertility and pregnancy outcomes.
The main questions the study aims to answer are:
Participants will:
The study is expected to run from January 2026 through December 2029. Data collected during the study may help improve the diagnosis and treatment of chronic endometritis in women with infertility and may support better reproductive outcomes in clinical practice.
Chronic endometritis (CE) is a chronic inflammatory condition of the endometrium characterized by plasma cell infiltration of the endometrial stroma. The condition is frequently asymptomatic or associated with nonspecific symptoms, which may contribute to underdiagnosis in women with infertility. Increasing evidence suggests that CE may negatively affect endometrial receptivity, embryo implantation, and reproductive outcomes, including recurrent implantation failure and pregnancy loss.
The MORE study is a prospective cohort study designed to evaluate the prevalence, diagnosis, treatment response, and reproductive impact of CE in women undergoing infertility evaluation. The study will enroll women aged 18 to 40 years with diagnosed infertility who are scheduled for diagnostic hysteroscopy with endometrial biopsy. Approximately 100 participants are expected to be enrolled between January 2026 and December 2029.
The study will assess the prevalence of histologically confirmed CE using histopathological evaluation combined with immunohistochemical detection of plasma cells (CD138 staining). Hysteroscopic findings suggestive of CE, including endometrial hyperemia, stromal edema, micropolyps, and abnormal vascular patterns, will be systematically documented and correlated with histopathological results in order to evaluate the diagnostic value of hysteroscopic markers in routine clinical practice.
Participants diagnosed with CE will receive standardized antibiotic treatment according to institutional protocols. Following treatment, reproductive outcomes will be prospectively monitored for up to 12 months. Outcomes of interest include spontaneous conception, assisted reproductive technology (ART) outcomes, implantation rates, clinical pregnancy, ongoing pregnancy, live birth, and miscarriage rates. Pregnancy-related complications, including preeclampsia, placental disorders, premature rupture of membranes, preterm birth, and delivery complications, will also be evaluated in participants who achieve pregnancy.
The study will additionally investigate the relationship between the endometrial microbial environment and reproductive outcomes. Endometrial samples obtained during hysteroscopy may be analyzed to characterize microbial profiles associated with CE and treatment response. Particular attention will be paid to microorganisms previously associated with CE, including Escherichia coli, Enterococcus faecalis, Corynebacterium species, Klebsiella pneumoniae, Mycoplasma species, and sexually transmitted pathogens.
A retrospective control cohort will include infertile women who previously underwent hysteroscopy with endometrial biopsy. Archived endometrial tissue samples from these participants will undergo additional immunohistochemical evaluation for CE in order to compare reproductive outcomes between participants with and without histological evidence of CE.
Clinical, demographic, reproductive, laboratory, imaging, and treatment-related data will be collected from electronic medical records and entered into a secure REDCap database using structured electronic case report forms. Collected variables will include demographic characteristics, infertility history, prior ART treatment, hysteroscopic findings, histopathological and immunohistochemical results, antibiotic treatment details, reproductive outcomes, pregnancy complications, and neonatal outcomes.
Data quality assurance procedures will include structured data entry forms, predefined variable definitions, range and consistency checks, and periodic review of entered data by authorized study investigators. Source data verification will be performed using electronic medical records and pathology reports. All study data will be pseudonymized using unique study identification codes. Direct participant identifiers will be stored separately from study data in accordance with institutional data protection procedures and General Data Protection Regulation (GDPR) requirements. Access to the REDCap database will be restricted to authorized study personnel only.
The planned statistical analysis will primarily be descriptive. Results will be reported as absolute numbers, percentages, and 95% confidence intervals. Comparisons between subgroups will be performed using chi-square or Fisher exact tests for categorical variables and t-tests or Mann-Whitney U tests for continuous variables, depending on data distribution. A p-value below 0.05 will be considered statistically significant. Missing or incomplete data will be documented and analyzed according to predefined statistical procedures.
The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) principles, and GDPR requirements. The protocol and related study documents will be submitted for approval to the Ethics Committee of University Hospital Královské Vinohrady (FNKV), Prague, Czech Republic.
50 studies on the registry are indexed under Endometritis; 11 are open to participants now.
Browse Endometritis studies →Faculty Hospital Kralovske Vinohrady is the lead sponsor of 30 studies on the registry; 6 are open to participants now.
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The study population will consist of women aged 18-40 years with primary or secondary infertility undergoing diagnostic hysteroscopy with endometrial biopsy for infertility evaluation or suspected chronic endometritis (CE). Participants will be recruited at University Hospital Královské Vinohrady and collaborating reproductive medicine centers in Prague, Czech Republic. Eligible participants must provide written informed consent and agree to protocol-defined diagnostic procedures, antibiotic treatment if indicated, and prospective follow-up of reproductive outcomes. The study will include women with previous unsuccessful assisted reproductive technology (ART) cycles, recurrent implantation failure, recurrent pregnancy loss, or unexplained infertility. Approximately 100 participants are expected to be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prevalence of Chronic Endometritis
Assessment of the prevalence of histologically confirmed chronic endometritis (CE) in women with primary or secondary infertility undergoing diagnostic hysteroscopy with endometrial biopsy and immunohistochemical evaluation (CD138 staining).
Time frame: Baseline
Correlation Between Hysteroscopic Findings and Histopathological Diagnosis of Chronic Endometritis
Evaluation of the association between hysteroscopic features suggestive of CE and histopathological confirmation of CE using immunohistochemistry.
Time frame: Baseline
Eradication Rate of Chronic Endometritis After Antibiotic Therapy
Evaluation of the proportion of participants with histologically confirmed CE who achieve resolution of inflammatory findings following standardized antibiotic treatment.
Time frame: up to 18 weeks
Spontaneous Pregnancy Rate
Assessment of the proportion of participants achieving spontaneous conception following treatment for chronic endometritis.
Time frame: up to 52 weeks
Disorders of placental separation
Assessment of the rate of retained placenta after delivery
Time frame: up to 94 weeks
Embryo Transfer Success Rate
Evaluation of reproductive success following assisted reproductive technology (ART), including the proportion of successful embryo transfer cycles resulting in clinical pregnancy.
Time frame: up to 52 weeks
Ongoing Pregnancy Rate
Evaluation of pregnancies continuing beyond 12 completed weeks of gestation.
Time frame: up to 64 weeks
Preterm birth
Assessment of the rate of preterm birth before 37 weeks of gestation
Time frame: up to 89 weeks
Hypertensive disorders of pregnancy
Assessment of rate of hypertensive disorders of pregnancy
Time frame: up to 94 weeks
Live Birth Rate
Assessment of the proportion of participants achieving live birth following treatment for chronic endometritis.
Time frame: up to 94 weeks
Birth weight
Newborn birth weight in grams
Time frame: up to 94 weeks
Newborn Apgar score; An unabbreviated scale title: Appearance, Pulse, Grimace, Activity, and Respiration Score; Minimum value 0; Maximum value 10; Higher Apgar scores indicate a better newborn condition and a better immediate clinical outcome.
Apgar scores at 1, 5, and 10 minutes
Time frame: up tp 94 weeks
Plan to share: No
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Faculty Hospital Kralovske Vinohrady