Chronic EndometritisPhase 2NCT05205993
Εffectiveness of Intrauterine Antibiotic Administration for Treatment of Chronic Endometritis
A Phase 2 study testing Intrauterine infusion and Oral administration in people with Chronic Endometritis, run by Genesis Athens Clinic at 1 site in Greece.
Trial summary
Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion either separately or combined with oral antibiotic administration, and it assesses respective performance against the gold standard treatment of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Endometritis
- What is being tested?
- Intrauterine infusion and Oral administration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 19 Jan 2021to 30 Apr 2024
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Positive diagnosis of CE following hysteroscopy and endometrial biopsy (positive diagnosis is required by both evaluations)
- Signed Informed Consent
- 18.5 < BMI < 30
Who cannot join
- Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
- Current or previous cancer diagnosis
- Auto-immune or genetic disorders
- Menstrual cycle disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Genesis AC
Athens, 15232
Panagiotis Tzonis, MD, 6937115569, ptzonis@gmail.com
About this study
Official title: Investigating the Effectiveness of Innovative Intrauterine Antibiotic Therapy for the Treatment of Patients With Chronic Endometritis
Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion either separately or combined with oral antibiotic administration, and it assesses respective performance against the gold standard treatment of oral antibiotic adminstration. Data sourced herein reports on treatment efficiency, defined as a negative diagnosis for chronic endometritis.
Read the detailed description
An infectious endometrial environment caused by certain pathologies could compromise establishment of the initial interaction between the embryo and the endometrium. Chronic endometritis (CE) is a case of a persistent endometrial inflammation caused by infectious agents namely Escherichia Coli, Enterococcus faecalis, Streptococcus agalactiae, Mycoplasma, Ureaplasma, and Chlamydia. The perplexity of managing CE is attributed to its asymptomatic nature rendering a definitive diagnosis rather challenging. The list of potential symptoms is limited and vague while manifestation of the disease may be mild and may not correspond to severity. Symptoms include pain in the pelvic cavity, dispareunia, uterine bleeding, vaginal infections and cystitis, and mild gastro-intestinal discomfort. CE is described as a chronic disorder due to its long duration and persistent nature, with potentially slow progression and complex causality, severely compromising reproductive potential of patients.
The antibiotic treatments are primarily administered orally and endometrial re-examination is performed following treatment. It should be emphasized that apart from the differences in the types of antibiotics included, there are also significant discrepancies regarding the dosage of each antibiotic and the different schemes suggested by each practice. Following the antibiotic regime, endometrial receptivity is anticipated to improve. However, a significant correlation between the antibiotic therapeutic approach and a positive results in IVF has failed to be established in literature, indicating that oral antibiotic administration is unseccessful in improving IVF outcome.
A pilot study published by the investigators indicated that combination of intrauterine infusion of antibiotics and oral administration can be more effective in treating CE than solely oral administration. However, it has not been evaluated if sole intrauterine infusion of antibiotics can be of similar effectiveness when compared to the combined regime including intrauterine infusion and oral andministration, or when compared to the gold standard treatment including only oral administration of antibiotics.
- Conditions
- Chronic Endometritis
- Being tested
- Intrauterine infusion, Oral administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine infusionDrug
A total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
Oral administrationDrug
per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day and metronidazole of 500mg twice a day for a total of 30 days
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine infusion of antibiotics | Experimental | Thirty women will receive only intrauterine infusion of antibiotics for 30 days. Receives: Drug: Intrauterine infusion |
| Combination of intrauterine infusion and oral administration of antibiotics | Experimental | Thirty women will receive a combination of intrauterine infusion and oral administration of antibiotics for 30 days. Receives: Drug: Intrauterine infusion; Drug: Oral administration |
| Oral administration of antibiotics | Active comparator | Thirty women will receive only oral administration of antibiotics for 30 days. Receives: Drug: Oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative diagnosis of CE following hysteroscopy and endometrial biopsy
All participants will be subjected to hysteroscopy and endometrial biopsy following completion of treatment. Regarding hysteroscopy the presence of endometritis will be evaluated according to the published unified diagnostic criteria for CE. The endometrial biopsy will be performed employing a pipelle. To minimize contamination risk, following the placement of a vaginal speculum and cleaning external uterine ostium with an iodine solution, the pipelle will be inserted under visual control into the uterine cavity ensuring avoidance of any contact with vaginal walls. Endometrial samples will be diluted into 2 ml of saline for histological analysis. For histological analysis the endometrium samples will be fixated employing neutral formalin and paraffin. To stain the microsections, hematoxyline and eosin will be engaged. CD138 staining will be performed and positivity will indicate a CE diagnosis (>1 plasma cell per 10HPFs). A negative CE diagnosis should be confirmed by both assessments
Measured: Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-.
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Number of reports of side-effects according to CTCAE v6.0 per treated patients
Measured: Side-effects will be monitored for one month from treatment initiation which is until completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start19 Jan 2021
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic EndometritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genesis Athens Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Sponsor
- Investigators
- Konstantinos Sfakianoudis, MD, Principal investigator, Genesis Athens Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205993
- Sponsor's protocol ID
- IAI-1
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pantos K, Simopoulou M, Maziotis E, Rapani A, Grigoriadis S, Tsioulou P, Giannelou P, Nitsos N, Tzonis P, Koutsilieris M, Sfakianoudis K. Introducing intrauterine antibiotic infusion as a novel approach in effectively treating chronic endometritis and restoring reproductive dynamics: a randomized pilot study. Sci Rep. 2021 Aug 2;11(1):15581. doi: 10.1038/s41598-021-95072-w.
PubMed 34341409
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Innovative Intrauterine Antibiotic Therapy for the Treatment of Patients With Chronic Endometritis
- ClinicalTrials.gov ID
- NCT05205993
- Acronym / sponsor ID
- IAI-1
- Conditions
- Chronic Endometritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Genesis Athens ClinicUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 25 Jan 2022 (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.
Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion either separately or combined with oral antibiotic administration, and it assesses respective performance against the gold standard treatment of oral antibiotic adminstration. Data sourced herein reports on treatment efficiency, defined as a negative diagnosis for chronic endometritis.
Detailed description
An infectious endometrial environment caused by certain pathologies could compromise establishment of the initial interaction between the embryo and the endometrium. Chronic endometritis (CE) is a case of a persistent endometrial inflammation caused by infectious agents namely Escherichia Coli, Enterococcus faecalis, Streptococcus agalactiae, Mycoplasma, Ureaplasma, and Chlamydia. The perplexity of managing CE is attributed to its asymptomatic nature rendering a definitive diagnosis rather challenging. The list of potential symptoms is limited and vague while manifestation of the disease may be mild and may not correspond to severity. Symptoms include pain in the pelvic cavity, dispareunia, uterine bleeding, vaginal infections and cystitis, and mild gastro-intestinal discomfort. CE is described as a chronic disorder due to its long duration and persistent nature, with potentially slow progression and complex causality, severely compromising reproductive potential of patients.
The antibiotic treatments are primarily administered orally and endometrial re-examination is performed following treatment. It should be emphasized that apart from the differences in the types of antibiotics included, there are also significant discrepancies regarding the dosage of each antibiotic and the different schemes suggested by each practice. Following the antibiotic regime, endometrial receptivity is anticipated to improve. However, a significant correlation between the antibiotic therapeutic approach and a positive results in IVF has failed to be established in literature, indicating that oral antibiotic administration is unseccessful in improving IVF outcome.
A pilot study published by the investigators indicated that combination of intrauterine infusion of antibiotics and oral administration can be more effective in treating CE than solely oral administration. However, it has not been evaluated if sole intrauterine infusion of antibiotics can be of similar effectiveness when compared to the combined regime including intrauterine infusion and oral andministration, or when compared to the gold standard treatment including only oral administration of antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrauterine infusion of antibiotics | Experimental | Drug: Intrauterine infusionThirty women will receive only intrauterine infusion of antibiotics for 30 days. |
| Combination of intrauterine infusion and oral administration of antibiotics | Experimental | Drug: Intrauterine infusion, Drug: Oral administrationThirty women will receive a combination of intrauterine infusion and oral administration of antibiotics for 30 days. |
| Oral administration of antibiotics | Active comparator | Drug: Oral administrationThirty women will receive only oral administration of antibiotics for 30 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Positive diagnosis of CE following hysteroscopy and endometrial biopsy (positive diagnosis is required by both evaluations)
- Signed Informed Consent
- 18.5 < BMI < 30
Key exclusion criteria (4 listed)
- Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
- Current or previous cancer diagnosis
- Auto-immune or genetic disorders
- Menstrual cycle disorders
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 |
|---|---|---|
| Intrauterine infusionA total of 10 intrauterine infusions of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml | Drug | Combination of intrauterine infusion and oral administration of antibiotics, Intrauterine infusion of antibiotics |
| Oral administrationper os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day and metronidazole of 500mg twice a day for a total of 30 days | Drug | Combination of intrauterine infusion and oral administration of antibiotics, Oral administration of antibiotics |
Primary outcome
Negative diagnosis of CE following hysteroscopy and endometrial biopsy
Time frame: Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-.
All participants will be subjected to hysteroscopy and endometrial biopsy following completion of treatment. Regarding hysteroscopy the presence of endometritis will be evaluated according to the published unified diagnostic criteria for CE. The endometrial biopsy will be performed employing a pipelle. To minimize contamination risk, following the placement of a vaginal speculum and cleaning external uterine ostium with an iodine solution, the pipelle will be inserted under visual control into the uterine cavity ensuring avoidance of any contact with vaginal walls. Endometrial samples will be diluted into 2 ml of saline for histological analysis. For histological analysis the endometrium samples will be fixated employing neutral formalin and paraffin. To stain the microsections, hematoxyline and eosin will be engaged. CD138 staining will be performed and positivity will indicate a CE diagnosis (>1 plasma cell per 10HPFs). A negative CE diagnosis should be confirmed by both assessments
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: Side-effects will be monitored for one month from treatment initiation which is until completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 34341409Pantos K, Simopoulou M, Maziotis E, Rapani A, Grigoriadis S, Tsioulou P, Giannelou P, Nitsos N, Tzonis P, Koutsilieris M, Sfakianoudis K. Introducing intrauterine antibiotic infusion as a novel approach in effectively treating chronic endometritis and restoring reproductive dynamics: a randomized pilot study. Sci Rep. 2021 Aug 2;11(1):15581. doi: 10.1038/s41598-021-95072-w.
- 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.
Konstantinos Sfakianoudis, MD principal investigator
Genesis Athens Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrauterine infusion and Oral administration in people with Chronic Endometritis, run by Genesis Athens Clinic at 1 site in Greece.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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 Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Sfakianoudis, MD (2106894326, sfakianosc@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative diagnosis of CE following hysteroscopy and endometrial biopsy (time frame: Negative diagnosis of CE will be assessed in one month -immidiately after treatment completion-.). 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 NCT05205993, which also lists 1 linked publication.
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 24 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.