Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Genesis Athens Clinic80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Endometritis

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Human Reproduction LTD

Athens, Holargos, Greece

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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