NCT07603492 Fertility Outcomes After Antibiotic Treatment In Women With Chronic Endometritis
| NCT ID | NCT07603492 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Faculty Hospital Kralovske Vinohrady |
| Condition | Endometritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria * 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). Exclusion Criteria * 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. * 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.
Contact & Investigator
Borek Sehnal, MD,PhD.
PRINCIPAL INVESTIGATOR
Faculty Hospital Královské Vinohrady, Prague
Frequently Asked Questions
Who can join the NCT07603492 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Endometritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07603492 currently recruiting?
Yes, NCT07603492 is actively recruiting participants. Contact the research team at krystof.brecka@fnkv.cz for enrollment information.
Where is the NCT07603492 trial being conducted?
This trial is being conducted at Prague, Czechia, Prague, Czechia.
Who is sponsoring the NCT07603492 clinical trial?
NCT07603492 is sponsored by Faculty Hospital Kralovske Vinohrady. The principal investigator is Borek Sehnal, MD,PhD. at Faculty Hospital Královské Vinohrady, Prague. The trial plans to enroll 100 participants.