Fertility Outcomes After Antibiotic Treatment In Women With Chronic Endometritis

NCT07603492 | Recruiting

• 1 other identifier: VV/04/00/2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometritis; Infertility; Hysteroscopy; Pregnancy Disease

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  up to 18 weeks

Secondary Outcomes (7)

• Spontaneous Pregnancy Rate

  up to 52 weeks

• Disorders of placental separation

  up to 94 weeks

• Embryo Transfer Success Rate

  up to 52 weeks

• Ongoing Pregnancy Rate

  up to 64 weeks

• Preterm birth

  up to 89 weeks

Other Outcomes (2)

• Birth weight

  up to 94 weeks

• Newborn Apgar score

  up tp 94 weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (2)

Faculty Hospital Královské Vinohrady

Prague, 14000, Czechia

RECRUITING

PRONATAL Sanatorium

Prague, 14000, Czechia

RECRUITING

Related Publications (9)

• 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.

  PMID: 37012449 BACKGROUND

• Ilic 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.

  PMID: 41032339 BACKGROUND

• Cicinelli 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.

  PMID: 33863553 BACKGROUND

• Cicinelli 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.

  PMID: 31104760 BACKGROUND

• Cicinelli 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.

  PMID: 33722376 BACKGROUND

• Cicinelli 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.

  PMID: 29135053 BACKGROUND

• Yan 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.

  PMID: 40575265 BACKGROUND

• Xiong 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.

  PMID: 33926717 BACKGROUND

• Liu 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.

  PMID: 32240839 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

biopsy od endometrium

MeSH Terms

Conditions

Endometritis; Infertility

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Study Officials

• Borek Sehnal, MD,PhD.

  Faculty Hospital Královské Vinohrady, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krystof Brecka, MD

CONTACT

0042060417263; krystof.brecka@fnkv.cz

Borek Sehnal, MD, PhD.

CONTACT

borek.sehnal@fnkv.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)