Infertility UnexplainedNCT05946655

Diagnostics of Chronic Endometritis in Infertility

A study testing Ofloxacin + Metronidazole in people with Infertility Unexplained and Abnormal Uterine Bleeding, run by Jagiellonian University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Infertility Unexplained, Abnormal Uterine Bleeding, Intrauterine Disorder
What is being tested?: Ofloxacin + Metronidazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 sitePoland
Study dates: 1 Apr 2021to 30 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

age 18-45 years
lack of previous diagnosis and treatment due to suspected pathology of the uterine cavity
lack of active infection of the reproductive tract

Who cannot join

pelvic surgery performed within 6 months preceding the hysteroscopy
confirmed pelvic endometriosis
antibiotic or probiotic treatment within 3 months preceding the hysteroscopy

Trial locations and contacts

1 site in 1 country.

Poland1 site

Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, Malopolska, 31-501

Other trials in Poland

About this study

Official title: Evaluation of the Congruity of Methods Used in the Diagnostics of Chronic Endometritis in the Course of Infertility and the Effectiveness of Antibiotic Therapy in the Context of Remission of Symptoms and Obstetric Results

Chronic endometritis (CE) is characterized by the presence of atypical plasma cell infiltrates (CD138 positive) in the endometrial stroma. Recent analyzes suggest that CE adversely affects fertility by reducing endometrial receptivity, impairing decidualization and uterine contractility, thus increasing the risk of recurrent pregnancy loss and implantation failure. It is likely that a significant proportion of idiopathic infertility cases are due to CE. The diagnosis of CE is a challenge because the clinical examination and transvaginal ultrasonography are considered non-specific. The recent scientific research has been aimed at identifying hysteroscopic CE diagnostic criteria and establishing the compatibility of ultrasonographic, hysteroscopic, histopathological (including the use of immunohistochemical testing with antibodies against human CD138) and microbiological diagnoses. Preliminary literature results suggested that successful treatment of CE with antibiotics could improve live birth rates.

Read the detailed description

The objectives are as follows:

Estimation of the diagnostic congruity of hysteroscopic, histopathological and microbiological diagnoses of CE
Estimation of the effectiveness of empirical antibiotic therapy in the treatment of CE, confirmed by normalization of the hysteroscopic appearance of the uterine cavity, normalization of histopathological results of endometrial biopsies and decrease in plasma cell count/1 high power field (HPF)
Estimation of the percentage of clinical pregnancies achieved in women subjected to empiric antibiotic therapy for CE vs. in women without treatment. The study group will consist of women of childbearing age subjected to office hysteroscopy due to intrauterine pathologies, AUB, and idiopathic infertility. The prerequisite for hysteroscopy is a normal cervical cytology result, a negative blood pregnancy test, a normal vaginal biocenosis and the first phase of the cycle. During hysteroscopy, the following will be performed: visual inspection of the uterine cavity in search of focal lesions and features of the endometrium suggestive of CE, such as: focal or diffuse hyperemia, micropolyps, stromal edema, then collection of washings from the uterine cavity for microbiological examination (aerobic and anaerobic culture, PCR for Chlamydia, culture for Mycoplasma, Ureaplsma) and excision of the focal lesion or endometrial biopsy. The extracted tissue material will be subjected to standard histopathological examination with hematoxylin and eosin staining. Additional immunohistochemical staining with Monoclonal Mouse Anti-Human CD138 antibodies will be used to detect plasmocytes. The cut-off point for the number of CE-defining plasmocytes will be determined by the Receiver Operating Characteristic (ROC) curve. Women diagnosed with CE will be assigned to 2 arms: 1) ofloxacin 2x200 mg orally for 10 days + metronidazole 1x500 mg vaginally for 10 days, 2) control arm (no treatment). In the third cycle after the primary hysteroscopy, women will undergo a follow-up office hysteroscopy for a visual assessment of the uterine cavity and a follow-up endometrial biopsy. The percentage of women with improvement in the clinical appearance of the uterine cavity, normalization of histopathology and persistent CE in both arms will be determined. Data will be obtained on the results of infertility treatment (obtaining a clinical pregnancy) within 24 months of the procedure or completion of antibiotic therapy.

Conditions: Infertility Unexplained, Abnormal Uterine Bleeding, Intrauterine Disorder
Being tested: Ofloxacin + Metronidazole
Keywords: Infertility Unexplained, Chronic endometritis, Office hysteroscopy, Abnormal Uterine Bleeding
Medical subject headings: Metrorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ofloxacin + MetronidazoleDrug
Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days

Study groups in NCT05946655
Study group	Role	What they receive
Antibiotic therapy	Experimental	Women diagnosed with CE undergoing empirical antibiotic therapy Receives: Drug: Ofloxacin + Metronidazole
Control	No intervention	Women diagnosed with CE not subjected to empirical antibiotic therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Determination of the cut-off point of the number of plasma cells/1 HPF corresponding to histological CE
Diagnostic compatibility assessment of immunohistochemistry and histopathology will be performed to estimate the cut-off point for the number of plasma cells defining CE using the ROC (Receiver Operating Characteristic) curve
Measured: 3 months

Secondary outcomes (10)

Assessment of the reliability of polyp visualization in diagnosing CE
The percentage of women with CE and a hysteroscopy-visible endometrial polyp and without a polyp will be calculated and compared
Measured: 3 months
Assessment of the reliability of the visualization of focal endometrial hyperemia in the diagnosis of CE
The percentage of women with CE and hysteroscopy-visible focal hyperemia and without hyperaemia will be calculated and compared
Measured: 3 months
Assesment of the reliability of the visualization of diffuse endometrial hyperemia in the diagnosis of CE
The percentage of women with CE and hysteroscopy-visible diffuse hyperaemia and without hyperaemia will be calculated and compared
Measured: 3 months
Assessment of the reliability of the visualization of endometrial micropolyps in the diagnosis of CE
The percentage of women with CE and hysteroscopy-visible micropolyps and without micropolyps will be calculated and compared
Measured: 3 months
Assessment of the reliability of the visualization of endometrial edema in the diagnosis of CE
The proportion of women with CE and hysteroscopy-visible endometrial edema and without endometrial edema will be calculated and compared
Measured: 3 months
Evaluation of the effectiveness of antibiotic therapy in the context of reducing the number of plasma cells/1 mm2
The number of plasma cells/1 mm2 will be calculated and compared among women who received antibiotic therapy in the course of CE and untreated women
Measured: 3 months
Evaluation of the effectiveness of antibiotic therapy in the context of visual normalization of the uterine cavity in follow-up hysteroscopy
The percentage of women with persistent hysteroscopic CE symptoms: visualization of focal hyperemia or diffuse hyperemia or endometrial micropolyps or endometrial edema in follow-up hysteroscopy will be assessed and compared among women who received antibiotic therapy in the course of CE and untreated women
Measured: 3 months
Evaluation of the effectiveness of antibiotic therapy in the context of normalization of histopathological results of a control endometrial biopsy
The percentage of women with persistent histopathological CE symptoms: presence of plasma cells and/or other inflammatory cells (lymphocytes or neutrophilic granulocytes or histiocytes/macrophages or eosinophilic granulocytes) destructing the endometrial tubuli among women who received antibiotic therapy in the course of CE and untreated women will be evaluated and compared in follow-up hysteroscopic endometrial biopsy
Measured: 3 months
Evaluation of the effectiveness of antibiotic therapy in the treatment of CE - dependent infertility
Pregnancy rates will be assessed and compared among women who received antibiotics for CE and untreated women
Measured: 24 months
Evaluation of the effectiveness of antibiotic therapy in the treatment of CE - dependent abnormal uterine bleeding
The rates of persistence of abnormal uterine bleeding will be assessed and compared in women who received antibiotics for CE and in untreated women.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202130 Oct 2024

First posted14 Jul 2023
Study start1 Apr 2021
Primary completion30 Oct 2022
Study completion30 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infertility UnexplainedStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Prospective cohort study
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05946655
Sponsor's protocol ID: 1072.6120.322.2020
Status last verified: Apr 2025
First submitted: 29 Jun 2023
Last updated: 18 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Congruity of Methods Used in the Diagnostics of Chronic Endometritis in the Course of Infertility and the Effectiveness of Antibiotic Therapy in the Context of Remission of Symptoms and Obstetric Results
ClinicalTrials.gov ID: NCT05946655
Acronym / sponsor ID: 1072.6120.322.2020
Conditions: Infertility Unexplained, Abnormal Uterine Bleeding, Intrauterine Disorder
Keywords: Infertility Unexplained, Chronic endometritis, Office hysteroscopy, Abnormal Uterine Bleeding
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Jagiellonian UniversityUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 30 Oct 2022 (actual)
Study completion: 30 Oct 2024 (actual)
First posted: 14 Jul 2023 (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.

Detailed description

The objectives are as follows:

Estimation of the diagnostic congruity of hysteroscopic, histopathological and microbiological diagnoses of CE
Estimation of the effectiveness of empirical antibiotic therapy in the treatment of CE, confirmed by normalization of the hysteroscopic appearance of the uterine cavity, normalization of histopathological results of endometrial biopsies and decrease in plasma cell count/1 high power field (HPF)
Estimation of the percentage of clinical pregnancies achieved in women subjected to empiric antibiotic therapy for CE vs. in women without treatment. The study group will consist of women of childbearing age subjected to office hysteroscopy due to intrauterine pathologies, AUB, and idiopathic infertility. The prerequisite for hysteroscopy is a normal cervical cytology result, a negative blood pregnancy test, a normal vaginal biocenosis and the first phase of the cycle. During hysteroscopy, the following will be performed: visual inspection of the uterine cavity in search of focal lesions and features of the endometrium suggestive of CE, such as: focal or diffuse hyperemia, micropolyps, stromal edema, then collection of washings from the uterine cavity for microbiological examination (aerobic and anaerobic culture, PCR for Chlamydia, culture for Mycoplasma, Ureaplsma) and excision of the focal lesion or endometrial biopsy. The extracted tissue material will be subjected to standard histopathological examination with hematoxylin and eosin staining. Additional immunohistochemical staining with Monoclonal Mouse Anti-Human CD138 antibodies will be used to detect plasmocytes. The cut-off point for the number of CE-defining plasmocytes will be determined by the Receiver Operating Characteristic (ROC) curve. Women diagnosed with CE will be assigned to 2 arms: 1) ofloxacin 2x200 mg orally for 10 days + metronidazole 1x500 mg vaginally for 10 days, 2) control arm (no treatment). In the third cycle after the primary hysteroscopy, women will undergo a follow-up office hysteroscopy for a visual assessment of the uterine cavity and a follow-up endometrial biopsy. The percentage of women with improvement in the clinical appearance of the uterine cavity, normalization of histopathology and persistent CE in both arms will be determined. Data will be obtained on the results of infertility treatment (obtaining a clinical pregnancy) within 24 months of the procedure or completion of antibiotic therapy.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective cohort study

Arm	Type	Receives
Antibiotic therapy	Experimental	Drug: Ofloxacin + MetronidazoleWomen diagnosed with CE undergoing empirical antibiotic therapy
Control	No intervention	–Women diagnosed with CE not subjected to empirical antibiotic therapy

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

age 18-45 years
lack of previous diagnosis and treatment due to suspected pathology of the uterine cavity
lack of active infection of the reproductive tract

Key exclusion criteria (3 listed)

pelvic surgery performed within 6 months preceding the hysteroscopy
confirmed pelvic endometriosis
antibiotic or probiotic treatment within 3 months preceding the hysteroscopy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ofloxacin + MetronidazoleOfloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days	Drug	Antibiotic therapy

Primary outcome

Determination of the cut-off point of the number of plasma cells/1 HPF corresponding to histological CE
Time frame: 3 months
Diagnostic compatibility assessment of immunohistochemistry and histopathology will be performed to estimate the cut-off point for the number of plasma cells defining CE using the ROC (Receiver Operating Characteristic) curve

10 secondary outcomes

Assessment of the reliability of polyp visualization in diagnosing CE
Time frame: 3 months
Assessment of the reliability of the visualization of focal endometrial hyperemia in the diagnosis of CE
Time frame: 3 months
Assesment of the reliability of the visualization of diffuse endometrial hyperemia in the diagnosis of CE
Time frame: 3 months
Assessment of the reliability of the visualization of endometrial micropolyps in the diagnosis of CE
Time frame: 3 months
Assessment of the reliability of the visualization of endometrial edema in the diagnosis of CE
Time frame: 3 months
Evaluation of the effectiveness of antibiotic therapy in the context of reducing the number of plasma cells/1 mm2
Time frame: 3 months
Evaluation of the effectiveness of antibiotic therapy in the context of visual normalization of the uterine cavity in follow-up hysteroscopy
Time frame: 3 months
Evaluation of the effectiveness of antibiotic therapy in the context of normalization of histopathological results of a control endometrial biopsy
Time frame: 3 months
Evaluation of the effectiveness of antibiotic therapy in the treatment of CE - dependent infertility
Time frame: 24 months
Evaluation of the effectiveness of antibiotic therapy in the treatment of CE - dependent abnormal uterine bleeding
Time frame: 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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. This study is not recruiting at the moment.

Robert Jach, Prof., PhD study chair

Jagiellonian University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ofloxacin + Metronidazole in people with Infertility Unexplained and Abnormal Uterine Bleeding, run by Jagiellonian University at 1 site in Poland.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the cut-off point of the number of plasma cells/1 HPF corresponding to histological CE (time frame: 3 months). 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 NCT05946655.

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 18 Apr 2025.