Determination of the effect of oral levofloxacin on refractory chronic endometritis in patients with recurrent implantation failure
Design
The study is a clinical trial, in parallel and double-blind, which will be performed on 60 people by block stratified randomization.
Settings and conduct
This is a double-blind study in which participants, health professionals, researchers, evaluators do not know whether the patient is receiving medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria included women with chronic endometritis with fetal transfer failure confirmed by histology. َAso exclusion criteria include hypersensitivity to doxycycline and metronidazole and deficiency of glucose-6-phosphate dehydrogenase enzyme.
Intervention groups
The study consists of an intervention group.
Main outcome variables
Endometrial infection resolves after levofloxacin treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220413054524N1
Registration date:2022-05-09, 1401/02/19
Registration timing:registered_while_recruiting
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Maryam Nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
mary.nemati2022@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral levofloxacin on refractory chronic endometritis in patients with recurrent implant failure
Public title
Evaluation of the effect of oral levofloxacin on chronic endometritis in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females with chronic endometritis with fetal transfer failure confirmed by histology using histology
Exclusion criteria:
Sensitivity to doxycycline
Allergy to metronidazole
Glucose 6 phosphate dehydrogenase deficiency
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals in the method of permutation blocks with a volume of 4 people in 15 blocks that are assigned to one of the intervention or control groups. Endometrial sampling (second sample) will continue until 60 patients with refractory endometritis are available. Patients with endometritis in the second sample of endometrium are randomly divided into two groups of intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the drugs are coded A and B. None of the participants, health personnel, researchers, evaluators, and analysts know which drug code and which placebo code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahre-Kord University of Medical Sciences
Street address
Kashani ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.SKUMS,MED.REC.1400.020
Health conditions studied
1
Description of health condition studied
Endometritis
ICD-10 code
N71.9
ICD-10 code description
Inflammatory disease of uterus, unspecified
Primary outcomes
1
Description
Endometritis
Timepoint
Before the intervention and the next menstrual cycle
Method of measurement
Perform a biopsy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use levofloxacin for 7 days and have a biopsy for endometritis in the next menstrual cycle.
Category
Treatment - Drugs
2
Description
Control group: They will receive a placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
AbdolMajid Taheri
Street address
Hajar hospital, Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 1943
Email
Hajar-Hospital@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehreban Sadeghi
Street address
Kashani ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Bakhiyari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital,Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 1943
Email
shghyeghbakhtiyari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati Dehkordi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital,Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 1943
Email
mertanem@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahla Taheri
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Hajar hospital,Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 1943
Email
Hajar-Hospital@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Maryam Nemati, Department of Obstetrics and Gynecology, Hajar Hospital, Parstar St., Shahre-kord
What processes are involved for a request to access data/document