Protocol summary

Study aim
To compare following variables in different study arms: number of embryos and oocytes, quality of embryo, age of parents, uterous anomaly, method of embryo transfer, traumatization, ET difficulty, fertilization rate, implantation rate, preterm labor, PROM, early abortion with FHR, early abortion without FHR, chemical pregnancy, life birth rate in different study arms (clindamycin suppository-lactobacilli suppository-placebo)
Design
Clinical trial with placebo group, with parallel groups, single-blinded, randomized with permuted block randomization with sample size of 108 patients
Settings and conduct
All patients candidate for IVF referring to Omid clinic, Hamedan, Iran are enrolled in this study. Patients who are enrolled in the study will receive treatment by a care provider who is blinded to the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients candidate for IVF referring to Omid clinic, Hamedan, Iran. Exclusion criteria included poor responder patients and those with severe male infertility
Intervention groups
Clindamycin suppository, Lactobacilli suppository, Placebo
Main outcome variables
Implantaion rate, PROM, Abortion, Life birth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200819048456N1
Registration date: 2021-01-06, 1399/10/17
Registration timing: registered_while_recruiting

Last update: 2021-01-06, 1399/10/17
Update count: 0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
roghayeh anvari aliabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 8080
Email address
anvar_anvari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Clindamycin suppository and Lactobacilli suppository in vaginal microbiome on in-vitro fertilization (IVF) in patients candidate for embryo transfer referring to Omid clinic, Hamedan: single blind randomized clinical trial
Public title
The effect of Clindamycin and Lactobacilli suppository on in-vitro fertilization (IVF) results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for IVF referring to Omid clinic, Hamedan, Iran
Exclusion criteria:
Poor responder Severe male infertility
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
  • Care provider
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
we used permuted block randomization in this study. patients were randomly assigned to 3 blocks (each containing 6 persons).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who are clinically asymptomatic will be enrolled in the study and receive treatment by a care provider who is blinded to the type of drugs
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Fatemieh hospital, Pasdaran street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Approval date
2020-10-25, 1399/08/04
Ethics committee reference number
IR.UMSHA.REC.1399.613

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Implantation rate
Timepoint
2 weeks
Method of measurement
Sonography

Secondary outcomes

1

Description
Prelabor rupture of membranes
Timepoint
22 to 37 weeks
Method of measurement
Yes/ no questionnaire

2

Description
Life birth rate
Timepoint
38 weeks
Method of measurement
Yes/ no questionnaire

3

Description
Abortion rate
Timepoint
12 weeks
Method of measurement
Yes/ no questionnaire

Intervention groups

1

Description
Intervention group: clindamycin suppository
Category
Treatment - Drugs

2

Description
Intervention group: lactobacilli suppository
Category
Treatment - Drugs

3

Description
Control group: placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid clinic, Hamedan
Full name of responsible person
Roghayeh Anvari Aliabad
Street address
Fatemieh hospital, Pasdaran street
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
anvar_anvari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Fahmideh street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0924
Email
Pub@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Roghayeh Anvari aliabad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran square, Fatemiyeh hospital
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 8080
Fax
Email
anvar_anvari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Roghayeh Anvari aliabad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran square, Fatemiyeh hospital
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 8080
Fax
Email
anvar_anvari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Roghayeh Anvari aliabad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran square, Fatemiyeh hospital
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 8080
Fax
Email
anvar_anvari@yahoo.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
data for the method of RCT and primary outcome will be published
When the data will become available and for how long
6 months after publish of results
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
after sending the research proposal, data will be available
From where data/document is obtainable
via email : anvar_anvari@yahoo.com
What processes are involved for a request to access data/document
access to the data will be available as soon as possible after reading the research proposal
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