Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

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

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 Overview

• Status: Completed
• Conditions: Chronic Endometritis
• Intervention / Treatment: Drug: Oral antibiotic administration; Drug: Intrauterine antibiotic infusion

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Holargos
    • Athens, Holargos, Greece, 15562
      • Human Reproduction LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Genesis Athens Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): January 3, 2020

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: infertility; CE treatment; oral antibiotic administration; intrauterine antibiotic infusion
• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Endometritis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 1A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No