Chronic EndometritisPhase 2NCT04447625
Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics
A Phase 2 study testing Oral antibiotic administration and Intrauterine antibiotic infusion 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 (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Chronic Endometritis
- What is being tested?
- Oral antibiotic administration and Intrauterine antibiotic infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2017to 3 Jan 2020
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Positive diagnosis of CE
- Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF)
- No previous live birth
- FSH and LH levels -evaluated on day 2 of the menstrual cycle- <12 IU/ml
- AMH levels >1.1ng/ml
- Progesterone levels -evaluated on day 21 of the menstrual cycle- > 2 and <25 ng/ml
- 18.5<BMI<29.9
- 18<Patients' age<40
Who cannot join
- Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
- Current or previous cancer diagnosis
- Auto-immune, genetic or reproductive disorders
- Reproductive history of pregnancy loss due to genetic abnormalities
- Male factor infertility diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study
Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).
- Conditions
- Chronic Endometritis
- Being tested
- Oral antibiotic administration, Intrauterine antibiotic infusion
- Keywords
- CE treatment, infertility, oral antibiotic administration, intrauterine antibiotic infusion
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antibiotic administrationDrug
per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days
Intrauterine antibiotic infusionDrug
intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
| Study group | Role | What they receive |
|---|---|---|
| CE patients receiving OAA | Active comparator | Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA) Receives: Drug: Oral antibiotic administration |
| CE patients receiving OAA and IAI | Experimental | Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI) Receives: Drug: Oral antibiotic administration; Drug: Intrauterine antibiotic infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficiency rate
Negative results in all three diagnostic evaluations of CE namely hysteroscopic investigation, endometrial biopsy, along with histological analysis and microbiological culture indicating successful treatment of CE
Measured: Treatment efficiency rate was assessed immediately after treatment completion
Side-effects rate
Number of reports of minimal, mild, and moderate side-effects per treated patients
Measured: Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2
Secondary outcomes (2)
Clinical pregnancy rate
Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP)
Measured: Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.
Live birth rate
Number of live births per clinical pregnancy
Measured: A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Mar 2017
- Primary completion28 Feb 2019
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Athens Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447625
- Sponsor's protocol ID
- 1A
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study
- ClinicalTrials.gov ID
- NCT04447625
- Acronym / sponsor ID
- 1A
- Conditions
- Chronic Endometritis
- Keywords
- CE treatment, infertility, oral antibiotic administration, intrauterine antibiotic infusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Genesis Athens ClinicUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 25 Jun 2020 (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 (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CE patients receiving OAA | Active comparator | Drug: Oral antibiotic administrationPatients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA) |
| CE patients receiving OAA and IAI | Experimental | Drug: Oral antibiotic administration, Drug: Intrauterine antibiotic infusionPatients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Positive diagnosis of CE
- Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF)
- No previous live birth
- FSH and LH levels -evaluated on day 2 of the menstrual cycle- <12 IU/ml
- AMH levels >1.1ng/ml
Key exclusion criteria (5 listed)
- Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
- Current or previous cancer diagnosis
- Auto-immune, genetic or reproductive disorders
- Reproductive history of pregnancy loss due to genetic abnormalities
- Male factor infertility diagnosis
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 |
|---|---|---|
| Oral antibiotic administrationper os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days | Drug | CE patients receiving OAA, CE patients receiving OAA and IAI |
| Intrauterine antibiotic infusionintrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml | Drug | CE patients receiving OAA and IAI |
Primary outcome
Treatment efficiency rate
Time frame: Treatment efficiency rate was assessed immediately after treatment completion
Negative results in all three diagnostic evaluations of CE namely hysteroscopic investigation, endometrial biopsy, along with histological analysis and microbiological culture indicating successful treatment of CE
Side-effects rate
Time frame: Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2
Number of reports of minimal, mild, and moderate side-effects per treated patients
2 secondary outcomes
Clinical pregnancy rate
Time frame: Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.
Live birth rate
Time frame: A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.
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 25 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral antibiotic administration and Intrauterine antibiotic infusion 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 8 inclusion and 5 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 25 Jun 2020. 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?
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?
Treatment efficiency rate (time frame: Treatment efficiency rate was assessed immediately after treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2020.