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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CE patients receiving OAA | Active Comparator | Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral antibiotic administration | Drug | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Reproduction LTD | Athens | Holargos | 15562 | Greece |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Intrauterine antibiotic infusion | Drug | intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml |
|
| 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. |