NCT04447625

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 20, 2020

Last Update Submit

June 23, 2020

Conditions

Chronic Endometritis

Keywords

CE treatmentinfertilityoral antibiotic administrationintrauterine antibiotic infusion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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.

  • Live birth rate

    A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.

Study Arms (2)

CE patients receiving OAA

ACTIVE COMPARATOR

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

Drug: Oral antibiotic administration

CE patients receiving OAA and IAI

EXPERIMENTAL

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 administrationDrug: Intrauterine antibiotic infusion

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

CE patients receiving OAACE patients receiving OAA and IAI
Intrauterine antibiotic infusionDRUG

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

CE patients receiving OAA and IAI

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • \<BMI\<29.9
  • \<Patients' age\<40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Reproduction LTD

Athens, Holargos, 15562, Greece

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 25, 2020

Study Start

March 1, 2017

Primary Completion

February 28, 2019

Study Completion

January 3, 2020

Last Updated

June 25, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)