Chronic Endometritis
Conditions
Keywords
CE treatment, infertility, oral antibiotic administration, intrauterine antibiotic infusion
Brief 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. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).
Interventions
DRUGOral antibiotic administration
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
DRUGIntrauterine antibiotic infusion
intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
Sponsors
Genesis Athens Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficiency rate | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 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. | Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP) |
| Live birth rate | A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period. | Number of live births per clinical pregnancy |
Countries
Greece
Outcome results
None listed