Fertility Outcomes After Antibiotic Treatment In Women With Chronic Endometritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorFaculty Hospital Kralovske Vinohrady

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

Spontaneous Pregnancy Rate

Assessment of the proportion of participants achieving spontaneous conception following treatment for chronic endometritis.

Time frame
up to 52 weeks
2

Disorders of placental separation

Assessment of the rate of retained placenta after delivery

Time frame
up to 94 weeks
3

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
4

Ongoing Pregnancy Rate

Evaluation of pregnancies continuing beyond 12 completed weeks of gestation.

Time frame
up to 64 weeks

Other outcomes

1

Birth weight

Newborn birth weight in grams

Time frame
up to 94 weeks
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.