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Monitoring of Reproductive Outcomes in Women With Chronic Endometritis: A Prospective Cohort Study on the Impact of Antibiotic Treatment on Fertility and Obstetric Outcomes

Status: Recruiting
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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).

Contact Information
Primary
Krystof Brecka, MD
krystof.brecka@fnkv.cz
0042060417263
Backup
Borek Sehnal, MD, PhD.
borek.sehnal@fnkv.cz
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 100
Sponsors
Leads: Faculty Hospital Kralovske Vinohrady

This content was sourced from clinicaltrials.gov