Effect local scratch endometrium on outcome pregnancy in women with previous failure intrauterine insemination
Design
interventional study that was conducted on a randomized clinical trials in infertility center during 6 months.340patients 170 case,170 control
Settings and conduct
340 women with infertile women in are divided into two groups of170 patients.the group referring to infertility clinic on odd days,is consulted to participate in design and intervention,and after receiving informed consenton 8-9 days of menstrual cycle,endometrial scratch using Pipelle catheter is performed,but patients referring in even days, will be without any intervention and are divided into control group.On the 14th day after IUI,the biochemical pregnancy rate is measured with positive beta-test.
Participants/Inclusion and exclusion criteria
Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI.Inclusion criteria:Patients are candidates for induction ovulation and intrauterine insemination.Normalized thyroid and prolactin function tests.Age range18 to 40 years. Having at least one healthy fallopian tube and normal uterine cavity. Normalized semen fluid or mild disorders.At least one year of infertility due to regular sexual intercourse 2-3 per week, despite using of preventive methods.Exclusion criteria:No consent to participate in the study.Poor Response patients. Disturbance thyroid function and high prolactin.Tubal abnormalities leading to infertility amoderate to severe in terms number and morphology sperm.People with polycybnormalities leading to infertility.Semen analysis disorder. polystic ovary syndrome
Intervention groups
receiveing or not receiving endometer scratch using paipel divided into two groups of control and scratch
Main outcome variables
Comparison of success rate of pregnancy in the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180731040659N1
Registration date:2018-09-03, 1397/06/12
Registration timing:prospective
Last update:2018-09-03, 1397/06/12
Update count:2
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Farzaneh Khastefekr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5631
Email address
farzanehkhastefekr@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local scratch of endometrium on the outcome of pregnancy in women with the previous failure of intrauterine insemination
Public title
Effect of local scratch of endometrium on the outcome of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI
Exclusion criteria:
1. No consent to participate in the study2. Poor Response patients3. Disturbance of thyroid function and high prolactin4. Tubal abnormalities leading to infertility5. Semen analysis disorder (moderate to severe in terms of number and morphology of sperm) 6. People with polycystic ovary syndrome
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
340
Randomization (investigator's opinion)
Not randomized
Randomization description
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,Dental Collage
Street address
Persian Goulf Blvd,Aliibn Abitalib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2018-06-17, 1397/03/27
Ethics committee reference number
IR.ZAUMS.REC.1397.144
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pregnancy
Timepoint
On the 14th day after IUI, the biochemical pregnancy rate is measured
Method of measurement
Serum pregnancy test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: on based receiving or no receiving endometrial scratch using paipel is divided
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
infertility clinic of Ali Ibn Abi Talib in Zahedan
Full name of responsible person
Farahnaz Farzaneh
Street address
Perian gulf ,Blvd.Ali Ebne abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Persian Goulf Blvd,Aliebnabitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
The University of Zahedan
Full name of responsible person
Farzaneh Khasteh Fekr
Position
Gynecology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Blvd,persian gulf,Ali ebn abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
7969155669
Phone
+98 54 3329 5631
Email
behzadahmadi27@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of of medical science Zahedan
Full name of responsible person
Farahnaz,Farzaneh
Position
Infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Infertility
Street address
Persian gulf,Blvd,Ali ebn abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Persian Goulf Blvd,AliebnAbitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com
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