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Effect of endometrial scratching on intra uterine insemination outcome in infertile couples in controlled ovarian stimulation cycles

Protocol summary

Study aim
Evaluation the effect of endometrial scratching on intra-uterine insemination outcome among infertile couples in controlled ovarian stimulation cycles
Design
Randomized trial with control group, with parallel group design
Settings and conduct
This study will be done at the infertility center of Hazrat Zeynab Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-42 year old women; normal uterine cavity; BMI <35 kg/m2. Exclusion criteria :any maternal underlying diseases
Intervention groups
Intervention group: Endometrial scratching 48 hours before IUI. Control group: Not having endometrial scratching 48 hours before IUI.
Main outcome variables
Clinical pregnancy rate, Chemical pregnancy rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190409043212N1
Registration date: 2019-06-30, 1398/04/09
Registration timing: registered_while_recruiting

Last update: 2019-06-30, 1398/04/09
Update count: 0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Sara Davoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
sdavoodi9798@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-15, 1398/03/25
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of endometrial scratching on intra uterine insemination outcome in infertile couples in controlled ovarian stimulation cycles
Public title
Effect of endometrial scratching on IUI outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18-42 years old Normal uterine cavity, without any endometrial polyp or lesion BMI < 35 kg/m2
Exclusion criteria:
Maternal underlying disease
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 243
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization :patients who has frozen embryo will be randomized based on the randomization table derived from the site: www.randomization.org.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.SUMS.REC.1398.146

Health conditions studied

1

Description of health condition studied
Infertility patients going IUI cycle
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Clinical pregnancy rate
Timepoint
2 months after embryo transfer
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Chemical pregnancy rate
Timepoint
14 days after transferring the embryo
Method of measurement
Pregnancy Test

Intervention groups

1

Description
Intervention group: Endometrial scratching 48 hours before IUI
Category
Treatment - Other

2

Description
Control group: Not endometrial scratching 48 hours before IUI
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrate Zeinab Hospital
Full name of responsible person
Sara Davoodi
Street address
Hazrate Zeinab Hospital, Defae moghadas square
City
Shiraz
Province
Fars
Postal code
7134544119
Phone
+98 71 3233 2365
Fax
+98 71 3233 2365
Email
saradavoodi9798@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348 -44119
Phone
+98 71 3235 2365
Fax
+98 71 3235 2365
Email
nabarresh1@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Davoodi
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
saradavoodi9798@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Amooee
Position
Infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
amooee@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Davoodi
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetrics department , Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 2365
Email
saradavoodi9798@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Hormonal data, ovarian stimulation data, pregnancy outcome
When the data will become available and for how long
Six months after acceptance of paper
To whom data/document is available
People who want to do work in this field and have scientific documentation can use this document.
Under which criteria data/document could be used
Valid scientific individuals by presenting relevant documents
From where data/document is obtainable
An email to corresponding author
What processes are involved for a request to access data/document
Accepting permission from the Shiraz University of Medical Sciences's security ward and confirming the receipt of the file
Comments
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