Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Chronic Endometritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447625
• Other study ID #: 1A
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: January 3, 2020

Study information

• Verified date: June 2020
• Source: Genesis Athens Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 3, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Endometritis
• Endometritis

Intervention

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
• Intrauterine antibiotic infusion
intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml

Locations

Country	Name	City	State
Greece	Human Reproduction LTD	Athens	Holargos

Sponsors (1)

Lead Sponsor	Collaborator
Genesis Athens Clinic

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.