Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Phase 2

Completed

• Conditions: Chronic Endometritis
• Interventions: Drug: Oral antibiotic administration; Drug: Intrauterine antibiotic infusion

• Registration Number: NCT04447625
• Lead Sponsor: Genesis Athens Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-02-28
• Study Completion: 2020-01-03
• Status Verified: 2020-06
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CE patients receiving OAA	Oral antibiotic administration	Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)
CE patients receiving OAA and IAI	Intrauterine antibiotic infusion	Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)
CE patients receiving OAA and IAI	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Human Reproduction LTD; 🇬🇷 Athens, Holargos, Greece