Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Study Overview
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Brief Summary
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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).

Official Title
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Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study

Conditions
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Chronic Endometritis

Intervention / Treatment
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* Drug: Oral antibiotic administration
* Drug: Intrauterine antibiotic infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CE patients receiving OAA<br>Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA) | Drug: Oral antibiotic administration<br>* 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<br>|
| Experimental: CE patients receiving OAA and IAI<br>Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI) | Drug: Oral antibiotic administration<br>* 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<br>Drug: Intrauterine antibiotic infusion<br>* intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP) | 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 | A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CE treatment, infertility, oral antibiotic administration, intrauterine antibiotic infusion