Determining the effect of intrauterine injection ciprofloxacin on chronic endometritis in patients with repeated implantation failure.
Design
This one-sided blind clinical trial study will be conducted in the form of a before and after comparison (without a control group) on 30 infertile women with an unknown cause of endometritis referring to Hajar Shahrekord Hospital.The antibiotic regimen of drsoxycycline every 12 hours for 21 days and metronidazole 500 mg every 12 hours for 14 days will continue. In the next menstrual period, sampling will be done, in case of chronic endometritis, ciprofloxacin infusion solution with a concentration of 200 mg/100 ml in the form of 3 ml intrauterine infusion every 3 days using a 23 cm fetal replacement catheter. meter will be done. Therefore, the treatment cycle will be set for a period of one month including 10 infusions
Settings and conduct
This study infertile women suffering from endometritis with an unknown cause referred to Hajer Shahrekord Hospital in 1402-1401, in order to evaluate the effect of intrauterine injection ciprofloxacin on Chronic endometritis are studied.
Participants/Inclusion and exclusion criteria
Women with chronic endometritis
At least 3 failed embryo transfers
Having informed consent
Intervention groups
Ciprofloxacin infusion solution of 200 mg/100 ml every 3 days via a 23 cm fetal replacement catheter in the form of a 3 ml intrauterine infusion
Main outcome variables
Reducing endometritis, Increasing the chance of fertility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230111057108N1
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Farzaneh Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
nemati.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intrauterine injection of ciprofloxacin on chronic endometritis in patients recurrent implantation failure
Public title
Evaluation of the effect of intrauterine injection of ciprofloxacin on chronic endometritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Women with chronic endometritis with embryo transfer failure
Confirmation of infection using histology and hysteroscopy
At least 3 with unsuccessful embryo transfer without genetic, metabolic or endocrine causes
Exclusion criteria:
Hypersensitivity to doxycycline and ciprofloxacin
Unwillingness to continue participating in the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data before and after the intervention are unknown to the analyzer.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street
City
Shahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.SKUMS.MED.REC.1401.012
Health conditions studied
1
Description of health condition studied
Endometritis - Recurrent implantation failure
ICD-10 code
N80.0
ICD-10 code description
Endometriosis of uterus
Primary outcomes
1
Description
Reduction of histological symptoms related to endometritis
Timepoint
Before and one month after receiving the medicine
Method of measurement
Laboratory (mild-moderate-severe)
Secondary outcomes
1
Description
Increase the chance of fertility
Timepoint
After receiving the medicine
Method of measurement
Fertility percentage
Intervention groups
1
Description
Intervention group: The antibiotic regimen of drsoxycycline every 12 hours for 21 days and metronidazole 500 mg every 12 hours for 14 days will continue. In the next menstrual period, sampling will be done, in case of chronic endometritis, ciprofloxacin infusion solution with a concentration of 200 mg/100 ml in the form of 3 ml intrauterine infusion every 3 days using a 23 cm fetal replacement catheter. meter will be done. Therefore, the treatment cycle will be set for a period of one month including 10 infusions
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Shahrekord Hospital
Full name of responsible person
Farzaneh Ahmadi
Street address
Nurse St., Hajar Hospital
City
Shahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 21 8670 5503
Email
nemati.m@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeisi
Street address
Kashani street
City
Shahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
nemati.m@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
Farzaneh Ahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nurse St. - Hajar Hospital
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Phone
+98 38 3222 0016
Email
nemati.m@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farzaneh Ahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nurse St. - Hajar Hospital
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Phone
+98 38 3222 0016
Email
nemati.m@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farzaneh Ahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nurse St. - Hajar Hospital
City
Shahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Phone
+98 38 3222 0016
Email
nemati.m@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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