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Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Primary Purpose

Chronic Endometritis

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Oral antibiotic administration
Intrauterine antibiotic infusion
Sponsored by
Genesis Athens Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Endometritis focused on measuring CE treatment, infertility, oral antibiotic administration, intrauterine antibiotic infusion

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Human Reproduction LTD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CE patients receiving OAA

CE patients receiving OAA and IAI

Arm Description

Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)

Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)

Outcomes

Primary Outcome Measures

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
Side-effects rate
Number of reports of minimal, mild, and moderate side-effects per treated patients

Secondary Outcome Measures

Clinical pregnancy rate
Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP)
Live birth rate
Number of live births per clinical pregnancy

Full Information

First Posted
June 20, 2020
Last Updated
June 23, 2020
Sponsor
Genesis Athens Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04447625
Brief Title
Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics
Official Title
Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genesis Athens Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Endometritis
Keywords
CE treatment, infertility, oral antibiotic administration, intrauterine antibiotic infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CE patients receiving OAA
Arm Type
Active Comparator
Arm Description
Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)
Arm Title
CE patients receiving OAA and IAI
Arm Type
Experimental
Arm Description
Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)
Intervention Type
Drug
Intervention Name(s)
Oral antibiotic administration
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intrauterine antibiotic infusion
Intervention Description
intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
Primary Outcome Measure Information:
Title
Treatment efficiency rate
Description
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
Title
Side-effects rate
Description
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 Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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.
Title
Live birth rate
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Human Reproduction LTD
City
Athens
State/Province
Holargos
ZIP/Postal Code
15562
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

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