Protocol summary

Study aim
Comparison of the effect of oral metronidazole and vaginal probiotics on vaginal microbial flora and investigation of treatment failure in women with bacterial vaginosis.
Design
The present study is a clinical trial without a control group, with parallel groups, double-blind, randomized (using block randomization), phase 3 on 110 patients.
Settings and conduct
In this double-blind randomization clinical trial, women candidates for hysterosalpingography will be divided into two equal groups of azithromycin and doxydoxycycline by block randomization. In the azithromycin group, patients will receive 1 gram of oral azithromycin as a single dose, and in the doxycycline group, doxycycline 100 mg tablets orally twice a day for 5 days. Finally, the two groups are compared in terms of outcomes.
Participants/Inclusion and exclusion criteria
Conditions for inclusion in the study: 18-55-year-old women who are candidates for hysterosalpingography, referring to the obstetrics and gynecology clinic, infertility clinic, Amir-al Mominin Hospital, Arak; Consent to participate in the study. Conditions for inclusion in the study: History of acute Pelvic inflammatory disease within two months prior to Hysterosalpingography; history of gynecological surgery and other transcervical procedures within two months prior to Hysterosalpingography; The use of multiple antibiotics within two months before hysterosalpingography.
Intervention groups
In the azithromycin group, before the hysterosalpingography, the patients in the azithromycin group received a single dose of 1 gram of oral azithromycin, and in the doxycycline group, before the hysterosalpingography, the patients in the doxycycline group received 100 mg of doxycycline twice a day for 5 days
Main outcome variables
Fever, side effects, uterine and cervical infection, chlamydial infection, need to treat pelvic inflammatory disease, Prophylaxis satisfaction.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N15
Registration date: 2023-06-20, 1402/03/30
Registration timing: prospective

Last update: 2023-06-20, 1402/03/30
Update count: 0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of azithromycin and doxycycline in infection caused by hysterosalpingography
Public title
Comparison of the effect of two drugs, azithromycin and doxycycline, on infection after hysterosalpingography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-55-year-old women who are candidates for hysterosalpingography, referring to the obstetrics and gynecology clinic, infertility clinic, Amir-al Mominin Hospital, Arak Consent to participate in the study
Exclusion criteria:
History of acute Pelvic inflammatory disease within two months prior to Hysterosalpingography, to prevent incompletely treated or residual active Pelvic inflammatory disease. history of gynecological surgery and other transcervical procedures within two months prior to Hysterosalpingography, to avoid confounding by other gynecological procedures. The use of multiple antibiotics within two months before hysterosalpingography, to identify the exact effect of each of the studied antibiotics without disturbing the interaction of multiple antibiotics.
Age
From 18 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.
Blinding (investigator's opinion)
Double blinded
Blinding description
For this, one group will receive single-dose azithromycin tablets, and the other group will receive a starch tablet that is similar to azithromycin, and in addition, the doxy group of patients received doxycycline, And in the azithromycin group, they will receive a starch tablet similar to doxycycline with the same duration and dose. Therefore, the women participating in the study are not aware of the type of medicine. In addition, for blinding of the second type, the medicines are given to the patients by the respected observer and each patient will be coded. Not informed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.ARAKMU.REC.1401.161

Health conditions studied

1

Description of health condition studied
Infection after hysterosalpingography
ICD-10 code
N71.0
ICD-10 code description
Acute inflammatory disease of uterus

Primary outcomes

1

Description
Fever
Timepoint
2 weeks after hysterosalpingography
Method of measurement
Thermometer

2

Description
side effects
Timepoint
2 weeks after hysterosalpingography
Method of measurement
Physical history

3

Description
Uterine and cervical infection
Timepoint
2 weeks after hysterosalpingography
Method of measurement
Physical examination

4

Description
Chlamydial infection
Timepoint
2 weeks after hysterosalpingography
Method of measurement
Perform PCR

5

Description
The need to treat pelvic inflammatory disease
Timepoint
2 weeks after hysterosalpingography
Method of measurement
History and physical examination

6

Description
Satisfaction with prophylaxis
Timepoint
2 weeks after hysterosalpingography
Method of measurement
A questionnaire made by the researcher

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before hysterosalpingography, patients in the azithromycin group receive a single dose of 1 gram of azithromycin.
Category
Treatment - Drugs

2

Description
Intervention group: Before hysterosalpingography, patients in the doxycycline group receive 100 mg of doxycycline twice a day for 5 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital, Arak
Full name of responsible person
Dr. Nazila Najdi
Street address
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 918 348 2398
Fax
+98 86 3222 2003
Email
najdinazila@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Email
salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Nazila Najdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Email
najdinazila@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fatemeh Safi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
safiarak95@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Haj mohammad hoseini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Email
najdinazila@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2023/11/20 to 2026/11/20 for 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
Academic researchers and university professors can make a request to use the data from Dr. Nazila Najdi after contacting the relevant professor by message or email. Dr. Nazila Najdi: Phone: 09183482398 Email: najdinazila@gmail.com Address: Vice Chancellor for Education,Ayatollah Taleghani Hospital, Arak, Iran
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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