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The Effect of endometrial scratch on pregnancy rate in intra uterine insemination cycle(IUI).

Protocol summary

Study aim
Evaluation of pregnancy rate using endometrial scratch on the third day of the cycle in an infertile couple of intrauterine insemination ( IUI )candidate.
Design
A randomized clinical trial study was randomly divided into two parallel groups by block randomization with a sample size of 60 in two groups of intervention and control (B, A). Random sequences based on random blocks of size 4 are recorded on a card and the cards in the envelope are arranged in order respectively.
Settings and conduct
A randomized clinical trial conducted on infertile female candidates for IUI in Valiasr Infertility Center that Randomly divided by block method into two intervention groups (endometrial scratch) and control (without an endometrial scratch).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: primary or secondary female infertility, Age(21-35), BMI(18-30), Normal hormonal Profile( FSH less than 10), Normal Thyroid, Open tubal and regular ovulation. Exclusion criteria: Sever male infertility, 3 or 4 stage of endometriosis, Tubal infertility, Abnormal Thyroid, Abnormal Prolactin, Fibroma, Systemic disease.
Intervention groups
Stimulation of ovulation with the one a day the Letrozole tab will be done the 3-7 day of menstrual cycle. when the diameters of 1-2 follicles reached more than 18 Millimeter, Human Chorionic Gonadotropin (HCG) is injected and 36-38 hours after IUI will be done. In the intervention group, in addition to the routine method, it is explained, On the 3rd cycle, by using catheter number 4, an endometrial scrub is performed. Patients undergo lithotomy and without anesthesia, an endometrial scratch on the posterior wall of the endometrium is injected by an infertility specialist. Control group: The routine procedure that described, is performed and endometrial scratch are not performed in this group.
Main outcome variables
Chemical pregnancy rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180624040214N1
Registration date: 2018-11-21, 1397/08/30
Registration timing: registered_while_recruiting

Last update: 2018-11-21, 1397/08/30
Update count: 0
Registration date
2018-11-21, 1397/08/30
Registrant information
Name
Mina Jafarabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of endometrial scratch on pregnancy rate in intra uterine insemination cycle(IUI).
Public title
Endometrial scratch on the incidence of pregnancy in intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
secondary or primary female infertility Unknown infertility Age(21-35) BMI(18-30) Normal hormonal profile(FSH lower than 10) Normal Thyroid Open uterine tubal Regular ovulation
Exclusion criteria:
Sever male infertility 3 or 4 stage of endometriosis Tubal infertility FSH>10 m IU/ML َAdenexal mass Abnormal Thyroid Abnormal Prolactin Fibroma Systemic disease
Age
From 21 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is using random blocks of size 4.Based on random blocks with the size 4, the first sample A-second A-third B-fourth B and so on continued until 120 samples were completed. A random sequence is performed using a number of sealed non-transparent envelopes, which randomly stores the random sequences onto the card, The cards in the envelope are placed in sequence respectively. The clinician examines patients in terms of entry and exit criteria, and the clinic's midwife allocates participants to the study groups randomly by randomization method.
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 Tehran University of Medical Sciences
Street address
6th floor, Ghods St, Keshavarz Blvd.Central Organization of the University, Deputy of Research and Technology of Tehran University of Medical Sciences .
City
Tehran
Province
Tehran
Postal code
14415
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.TUMS.VCR.REC.1397.533

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors

Primary outcomes

1

Description
Chemical pregnancy rate
Timepoint
ّFiftheen days after intra uterine insemination.
Method of measurement
Blood test of B-HCG

Secondary outcomes

1

Description
Abortion rate
Timepoint
Two months after the positive of pregnancy test
Method of measurement
Vaginal sonography

2

Description
Ectopic pregnancy
Timepoint
Two weeks after a positive pregnancy test
Method of measurement
Vaginal Sonography

Intervention groups

1

Description
Intervention group: Stimulation of ovulation with Letrozole will be done the 3-7 day when the diameters of 1-2 follicles reached more than 18 millimeters, HCG is injected and after 36-38 hours, IUI will be done. In the intervention group , in addition to the routine method, On the 3rd cycle, by using Karman cannula 4, an endometrial scrub performed. Patients undergo lithotomy and without anesthesia, an endometrial scratch on the posterior wall of the endometrium is injected by an infertility specialist.
Category
Treatment - Surgery

2

Description
Control group: Stimulation of ovulation with Letrozole will be done the 3-7 day when the diameters of 1-2 follicles reached more than 18 millimeters, HCG is injected and 36-38 hours after IUI will be done, But endometrial scratch is not performed in this group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Infertility Clinic Of Imam Khomeini Hospital
Full name of responsible person
Mina Jafarabadi
Street address
Infertility Clinic, 1st floor, No. 2, Vali-e-Asr Building, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14415
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
minajaf@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Central Organization of the University, Tehran University of Medical Sciences, 6th floor, Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14415
Phone
+98 21 8163 3686
Email
m.sahraian@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr .Zahra Ebrahimi
Position
Medical doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali Asr Infertility Clinic, Floor one, no 2 Vali Asr building , Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Email
drebrahimi1234@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr.Zahra Ebrahimi
Position
Medical Doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Clinic, Floor one, No 2, Vali Asr building , Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Email
dr.ebrahimi1234@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fedyeh Haghollahi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Vali Asr Health Resaerch Center, Floor one, No 2 Vali Asr building, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14145
Phone
+98 21 6658 1616
Email
fedyeh_hagh@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
keep up the secrets of the patients.
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
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