EndometritisMORENCT07603492
Fertility Outcomes After Antibiotic Treatment In Women With Chronic Endometritis
An observational study of Endometritis and Infertility, run by Faculty Hospital Kralovske Vinohrady at 2 sites in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometritis, Infertility, Hysteroscopy
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jan 2026to 1 Jan 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Female participants aged 18-40 years.
- Diagnosis of infertility (primary or secondary infertility).
- Indication for diagnostic hysteroscopy with endometrial biopsy as part of infertility evaluation.
- Suspected or confirmed chronic endometritis.
- Ability and willingness to provide written informed consent prior to any study-related procedures.
- Willingness to undergo protocol-defined antibiotic treatment.
- Willingness to comply with study procedures and follow-up assessments.
- Agreement to reproductive outcome monitoring following treatment, including spontaneous conception and pregnancies achieved through assisted reproductive technologies (ART).
Who cannot join
- Age >40 years.
- Current pregnancy.
- Known hypersensitivity or contraindication to tetracycline antibiotics or other study-related antibiotic therapy without a suitable alternative treatment option.
- Severe systemic disease or medical condition that, in the opinion of the investigator, could interfere with study participation, safety, or interpretation of study results.
- Active malignant disease requiring systemic treatment.
- HIV infection or other severe immunodeficiency disorder.
Show all 11Show fewer
- Acute pelvic inflammatory disease or clinically significant active genital tract infection requiring immediate treatment.
- Previous participation in this study.
- Inability to undergo planned hysteroscopy or endometrial biopsy.
- Inability or unwillingness to comply with study procedures or follow-up requirements.
- Failure or refusal to provide written informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Borek Sehnal, MD, PhD. contact
Czechia2 sites, 2 recruiting
- Recruiting
Faculty Hospital Královské Vinohrady
Prague, 14000
Krystof Brecka, MD, krystof.brecka@fnkv.cz
- Recruiting
PRONATAL Sanatorium
Prague, 14000
Tonko Mardesic, MD, PhD, 00420261711606, sanatorium@pronatal.cz
About this study
Official title: Monitoring of Reproductive Outcomes in Women With Chronic Endometritis: A Prospective Cohort Study on the Impact of Antibiotic Treatment on Fertility and Obstetric Outcomes
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.
Read more
The main questions the study aims to answer are:
- How common is chronic endometritis in women undergoing infertility evaluation?
- Does antibiotic treatment improve fertility and pregnancy outcomes in women with CE?
- Can hysteroscopic findings reliably predict CE confirmed by laboratory testing?
- Are specific bacteria associated with poorer reproductive outcomes? Researchers will enroll approximately 100 women aged 18 to 40 years with diagnosed infertility who are scheduled for hysteroscopy and endometrial biopsy as part of infertility evaluation. Participants with severe systemic disease, pregnancy, inability to undergo hysteroscopy or antibiotic treatment, or allergy to study antibiotics without a suitable alternative will not be included.
Participants will:
- Undergo diagnostic hysteroscopy and endometrial biopsy
- Have tissue samples examined using histopathology and immunohistochemistry to identify CE
- Receive standardized antibiotic treatment if CE is confirmed
- Be followed for up to 12 months after treatment to monitor fertility outcomes
- Continue follow-up during pregnancy, if pregnancy occurs, to assess pregnancy and delivery outcomes Researchers will evaluate spontaneous pregnancies, embryo transfer success, implantation rates, miscarriage rates, time to pregnancy, and live birth outcomes. Pregnancy complications such as preeclampsia, placental disorders, premature rupture of membranes, and preterm birth will also be recorded.
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.
Read the detailed description
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.
- Conditions
- Endometritis, Infertility, Hysteroscopy, Pregnancy Disease
- Medical subject headings
- Endometritis, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: up to 18 weeks
Secondary outcomes (7)
Spontaneous Pregnancy Rate
Assessment of the proportion of participants achieving spontaneous conception following treatment for chronic endometritis.
Measured: up to 52 weeks
Disorders of placental separation
Assessment of the rate of retained placenta after delivery
Measured: 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.
Measured: up to 52 weeks
Ongoing Pregnancy Rate
Evaluation of pregnancies continuing beyond 12 completed weeks of gestation.
Measured: up to 64 weeks
Preterm birth
Assessment of the rate of preterm birth before 37 weeks of gestation
Measured: up to 89 weeks
Hypertensive disorders of pregnancy
Assessment of rate of hypertensive disorders of pregnancy
Measured: up to 94 weeks
Live Birth Rate
Assessment of the proportion of participants achieving live birth following treatment for chronic endometritis.
Measured: up to 94 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for EndometritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kryštof Břečka, Faculty Hospital Kralovske Vinohrady
- Investigators
- Borek Sehnal, MD,PhD., Principal investigator, Faculty Hospital Královské Vinohrady, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603492
- Sponsor's protocol ID
- VV/04/00/2026
- Acronym
- MORE
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo JH, Mi HX. Comment on: Does antibiotic therapy for chronic endometritis improve clinical outcomes of patients with recurrent implantation failure in subsequent IVF cycles? a systematic review and meta-analysis. J Assist Reprod Genet. 2023 May;40(5):1225-1226. doi: 10.1007/s10815-023-02770-7. Epub 2023 Apr 4. No abstract available.
PubMed 37012449Ilic J, Issa J, Varinot J, Bouaziz J, Massin N, Haddad B, Touboul C, Mitri-Frangieh R, Darai E, Dabi Y. Chronic endometritis diagnosis and fertility outcomes: an old unresolved question. Reprod Fertil. 2025 Oct 1;6(4):e250016. doi: 10.1530/RAF-25-0016. Print 2025 Oct 1.
PubMed 41032339Cicinelli E, Cicinelli R, Vitagliano A. Antibiotic therapy for chronic endometritis and its reproductive implications: a step forward, with some uncertainties. Fertil Steril. 2021 Jun;115(6):1445-1446. doi: 10.1016/j.fertnstert.2021.03.025. Epub 2021 Apr 15. No abstract available.
PubMed 33863553Cicinelli E, Vitagliano A, Kumar A, Lasmar RB, Bettocchi S, Haimovich S; International Working Group for Standardization of Chronic Endometritis Diagnosis. Unified diagnostic criteria for chronic endometritis at fluid hysteroscopy: proposal and reliability evaluation through an international randomized-controlled observer study. Fertil Steril. 2019 Jul;112(1):162-173.e2. doi: 10.1016/j.fertnstert.2019.03.004. Epub 2019 May 16.
PubMed 31104760Cicinelli E, Resta L, Loizzi V, Pinto V, Santarsiero C, Cicinelli R, Greco P, Vitagliano A. Antibiotic therapy versus no treatment for chronic endometritis: a case-control study. Fertil Steril. 2021 Jun;115(6):1541-1548. doi: 10.1016/j.fertnstert.2021.01.018. Epub 2021 Mar 13.
PubMed 33722376Cicinelli E, Matteo M, Trojano G, Mitola PC, Tinelli R, Vitagliano A, Crupano FM, Lepera A, Miragliotta G, Resta L. Chronic endometritis in patients with unexplained infertility: Prevalence and effects of antibiotic treatment on spontaneous conception. Am J Reprod Immunol. 2018 Jan;79(1). doi: 10.1111/aji.12782. Epub 2017 Nov 14.
PubMed 29135053Yan X, Jiao J, Wang X. The pathogenesis, diagnosis, and treatment of chronic endometritis: a comprehensive review. Front Endocrinol (Lausanne). 2025 Jun 12;16:1603570. doi: 10.3389/fendo.2025.1603570. eCollection 2025.
PubMed 40575265Xiong Y, Chen Q, Chen C, Tan J, Wang Z, Gu F, Xu Y. Impact of oral antibiotic treatment for chronic endometritis on pregnancy outcomes in the following frozen-thawed embryo transfer cycles of infertile women: a cohort study of 640 embryo transfer cycles. Fertil Steril. 2021 Aug;116(2):413-421. doi: 10.1016/j.fertnstert.2021.03.036. Epub 2021 Apr 26.
PubMed 33926717Liu H, Song J, Zhang F, Li J, Kong W, Lv S, Zhang L, Yan L. A New Hysteroscopic Scoring System for Diagnosing Chronic Endometritis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1127-1132. doi: 10.1016/j.jmig.2019.08.035. Epub 2020 Mar 30.
PubMed 32240839
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Reproductive Outcomes in Women With Chronic Endometritis: A Prospective Cohort Study on the Impact of Antibiotic Treatment on Fertility and Obstetric Outcomes
- ClinicalTrials.gov ID
- NCT07603492
- Acronym / sponsor ID
- MORE / VV/04/00/2026
- Conditions
- Endometritis, Infertility, Hysteroscopy, Pregnancy Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How common is chronic endometritis in women undergoing infertility evaluation?
- Does antibiotic treatment improve fertility and pregnancy outcomes in women with CE?
- Can hysteroscopic findings reliably predict CE confirmed by laboratory testing?
- Are specific bacteria associated with poorer reproductive outcomes? Researchers will enroll approximately 100 women aged 18 to 40 years with diagnosed infertility who are scheduled for hysteroscopy and endometrial biopsy as part of infertility evaluation. Participants with severe systemic disease, pregnancy, inability to undergo hysteroscopy or antibiotic treatment, or allergy to study antibiotics without a suitable alternative will not be included.
Participants will:
- Undergo diagnostic hysteroscopy and endometrial biopsy
- Have tissue samples examined using histopathology and immunohistochemistry to identify CE
- Receive standardized antibiotic treatment if CE is confirmed
- Be followed for up to 12 months after treatment to monitor fertility outcomes
- Continue follow-up during pregnancy, if pregnancy occurs, to assess pregnancy and delivery outcomes Researchers will evaluate spontaneous pregnancies, embryo transfer success, implantation rates, miscarriage rates, time to pregnancy, and live birth outcomes. Pregnancy complications such as preeclampsia, placental disorders, premature rupture of membranes, and preterm birth will also be recorded.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Female participants aged 18-40 years.
- Diagnosis of infertility (primary or secondary infertility).
- Indication for diagnostic hysteroscopy with endometrial biopsy as part of infertility evaluation.
- Suspected or confirmed chronic endometritis.
- Ability and willingness to provide written informed consent prior to any study-related procedures.
Key exclusion criteria (11 listed)
- Age >40 years.
- Current pregnancy.
- Known hypersensitivity or contraindication to tetracycline antibiotics or other study-related antibiotic therapy without a suitable alternative treatment option.
- Severe systemic disease or medical condition that, in the opinion of the investigator, could interfere with study participation, safety, or interpretation of study results.
- Active malignant disease requiring systemic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Chronic Endometritis
Time frame: Baseline
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).
Correlation Between Hysteroscopic Findings and Histopathological Diagnosis of Chronic Endometritis
Time frame: Baseline
Evaluation of the association between hysteroscopic features suggestive of CE and histopathological confirmation of CE using immunohistochemistry.
Eradication Rate of Chronic Endometritis After Antibiotic Therapy
Time frame: up to 18 weeks
Evaluation of the proportion of participants with histologically confirmed CE who achieve resolution of inflammatory findings following standardized antibiotic treatment.
7 secondary outcomes
Spontaneous Pregnancy Rate
Time frame: up to 52 weeks
Disorders of placental separation
Time frame: up to 94 weeks
Embryo Transfer Success Rate
Time frame: up to 52 weeks
Ongoing Pregnancy Rate
Time frame: up to 64 weeks
Preterm birth
Time frame: up to 89 weeks
Hypertensive disorders of pregnancy
Time frame: up to 94 weeks
Live Birth Rate
Time frame: up to 94 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 37012449Guo JH, Mi HX. Comment on: Does antibiotic therapy for chronic endometritis improve clinical outcomes of patients with recurrent implantation failure in subsequent IVF cycles? a systematic review and meta-analysis. J Assist Reprod Genet. 2023 May;40(5):1225-1226. doi: 10.1007/s10815-023-02770-7. Epub 2023 Apr 4. No abstract available.
- Background: PubMed 41032339Ilic J, Issa J, Varinot J, Bouaziz J, Massin N, Haddad B, Touboul C, Mitri-Frangieh R, Darai E, Dabi Y. Chronic endometritis diagnosis and fertility outcomes: an old unresolved question. Reprod Fertil. 2025 Oct 1;6(4):e250016. doi: 10.1530/RAF-25-0016. Print 2025 Oct 1.
- Background: PubMed 33863553Cicinelli E, Cicinelli R, Vitagliano A. Antibiotic therapy for chronic endometritis and its reproductive implications: a step forward, with some uncertainties. Fertil Steril. 2021 Jun;115(6):1445-1446. doi: 10.1016/j.fertnstert.2021.03.025. Epub 2021 Apr 15. No abstract available.
- Background: PubMed 31104760Cicinelli E, Vitagliano A, Kumar A, Lasmar RB, Bettocchi S, Haimovich S; International Working Group for Standardization of Chronic Endometritis Diagnosis. Unified diagnostic criteria for chronic endometritis at fluid hysteroscopy: proposal and reliability evaluation through an international randomized-controlled observer study. Fertil Steril. 2019 Jul;112(1):162-173.e2. doi: 10.1016/j.fertnstert.2019.03.004. Epub 2019 May 16.
- Background: PubMed 33722376Cicinelli E, Resta L, Loizzi V, Pinto V, Santarsiero C, Cicinelli R, Greco P, Vitagliano A. Antibiotic therapy versus no treatment for chronic endometritis: a case-control study. Fertil Steril. 2021 Jun;115(6):1541-1548. doi: 10.1016/j.fertnstert.2021.01.018. Epub 2021 Mar 13.
- Background: PubMed 29135053Cicinelli E, Matteo M, Trojano G, Mitola PC, Tinelli R, Vitagliano A, Crupano FM, Lepera A, Miragliotta G, Resta L. Chronic endometritis in patients with unexplained infertility: Prevalence and effects of antibiotic treatment on spontaneous conception. Am J Reprod Immunol. 2018 Jan;79(1). doi: 10.1111/aji.12782. Epub 2017 Nov 14.
- Background: PubMed 40575265Yan X, Jiao J, Wang X. The pathogenesis, diagnosis, and treatment of chronic endometritis: a comprehensive review. Front Endocrinol (Lausanne). 2025 Jun 12;16:1603570. doi: 10.3389/fendo.2025.1603570. eCollection 2025.
- Background: PubMed 33926717Xiong Y, Chen Q, Chen C, Tan J, Wang Z, Gu F, Xu Y. Impact of oral antibiotic treatment for chronic endometritis on pregnancy outcomes in the following frozen-thawed embryo transfer cycles of infertile women: a cohort study of 640 embryo transfer cycles. Fertil Steril. 2021 Aug;116(2):413-421. doi: 10.1016/j.fertnstert.2021.03.036. Epub 2021 Apr 26.
- Background: PubMed 32240839Liu H, Song J, Zhang F, Li J, Kong W, Lv S, Zhang L, Yan L. A New Hysteroscopic Scoring System for Diagnosing Chronic Endometritis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1127-1132. doi: 10.1016/j.jmig.2019.08.035. Epub 2020 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Borek Sehnal, MD, PhD. contact
Borek Sehnal, MD,PhD. principal investigator
Faculty Hospital Královské Vinohrady, Prague
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometritis and Infertility, run by Faculty Hospital Kralovske Vinohrady at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krystof Brecka, MD (0042060417263, krystof.brecka@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Chronic Endometritis (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07603492, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.