A Phase 2 interventional study of Oral antibiotic administration and Intrauterine antibiotic infusion in Chronic Endometritis, sponsored by Genesis Athens Clinic. Completed at 1 site in Greece. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-06-25.
Sponsored by Genesis Athens Clinic · Phase 2, Interventional, and Treatment
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).
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 80 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Genesis Athens Clinic is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)
Drug: Oral antibiotic administration
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 · Drug: Intrauterine antibiotic infusion
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 infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
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
Time frame: 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
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
Clinical pregnancy rate
Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP)
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
Number of live births per clinical pregnancy
Time frame: A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Feb 2019, 23 months.
Of 30 phase 2 interventional studies under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 42. This study's 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Genesis Athens Clinic