Determining and comparing the effect of oral treatment with "metronidazole and levofloxacin" in comparison with "placebo" on the increased ivf success rate
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 260 couples
Settings and conduct
In this randomized double-blind clinical trial study, 260 couples with a history of at least two unsuccessful IVF who referred to Beheshti Hospital in Isfahan, will be included in the study and randomly divided into 2 groups. One group will receive antibiotic treatment and the other group will receive a placebo. The IVF result (successful or unsuccessful) will then be recorded and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included couples (male and female) with a previous unexplained diagnosis of infertility, a history of at least two previous failed IVFs, no antibiotics in the last trimester or before previous IVFs, no diabetes, and chronic kidney disease in Couples and consent to participate in the study. The exclusion criteria are antibiotic allergy.
Intervention groups
Intervention group: Couples (both men and women) are treated with metronidazole 500 mg oral tablet once every 12 hours for 14 days and levofloxacin 500 mg oral tablet once daily for up to seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle.
Control group: Couples (both men and women) are treated with two placebo tablet every twelve hours, one for 14 days and one daily for seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle.
Main outcome variables
Serum βHCG level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N24
Registration date:2021-02-20, 1399/12/02
Registration timing:registered_while_recruiting
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral metronidazole and levofloxacin on increased IVF success rate after at least two failed IVFs
Public title
The effect of metronidazole and levofloxacin on increased IVF success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Couples (male and female) diagnosed with previous unexplained infertility
History of at least two previous failed IVFs
Do not take antibiotics in the last trimester or before previous IVFs
Absence of diabetes and chronic kidney disease in couples
Couple consent to participate in the study
Exclusion criteria:
Allergy to the studied antibiotics
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 260 eligible couples will be non-randomly selected. Then random numbers are created by computer software "Random Allocation" and are automatically divided into two parts. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to a patient (a couple) and therefore they will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs "metronidazole with levofloxacin" and "placebo" were prepared by a pharmacist with similar shape, color, smell, and size and placed in coded packages, and provided to the researcher. He/She prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.MUI.MED.REC.1399.490
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Serum βHCG level
Timepoint
14 days after IVF
Method of measurement
ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Couples (both men and women) are treated with metronidazole 500 mg oral tablet once every 12 hours for 14 days and levofloxacin 500 mg oral tablet once daily for up to seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle.
Category
Treatment - Drugs
2
Description
Control group: Couples (both men and women) are treated with two placebo pills every twelve hours, one for 14 days and one daily for seven days. At the end of the course of antibiotic treatment, IVF will be performed for the couple at the same time as the ovulation of the next cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Elham Naghshineh
Street address
Motahari Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Fax
Email
naghshineh@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham Naghshineh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
naghshineh@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Naghshineh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
naghshineh@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Paria Alirezaei
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Beheshti Hospital.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
pariyaalirezaei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD