Investigation of the Effects of Endometrial Scratch on the Outcomes of Ovulation Induction Cycles in Patients with Recurrent Failure
Design
Clinical Trial on 45 Patients
Settings and conduct
In the present study, endometrial scratch is carried out in 45 women referred to Bam Infertility Clinic with at least three failed cycles of ovulation induction. The pregnancy rates will be reported and there is no control group. Data collection is carried out using a researcher-made checklist including demographic variables (age, occupation, history of previous medical conditions, duration of infertility) and research-specific variables including chemical pregnancy (BHCG level of higher than 200 within two weeks after a missed period), clinical pregnancy rate, pregnancy sac and fetal heart seen on ultrasound three weeks after BHCG test), and abortion (based on bleeding before the 20th week of pregnancy).
Participants/Inclusion and exclusion criteria
Infertile women with at least 3 failed ovulation induction cycles, Normal semen analysis, Between 15 and 40 years old, Ultrasound results indicating no uterine abnormalities and at least 10 antral follicles, No previous abdominal surgery, No severe PCO
Intervention groups
Endometrial scratch is performed by pipelle in patients referred to the infertility clinic, meeting inclusion criteria on days 21-26 of menstrual cycles.
Main outcome variables
Clinical Pregnancy Rate, Chemical Pregnancy Rate, Abortion Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120207008948N2
Registration date:2021-10-16, 1400/07/24
Registration timing:registered_while_recruiting
Last update:2021-10-16, 1400/07/24
Update count:0
Registration date
2021-10-16, 1400/07/24
Registrant information
Name
Sakineh Ebrahimipour
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
yasamin_m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Endometrial Scratch on the Results of Ovulation Induction Cycles in Patients with Recurrent Failure
Public title
Effect of Endometrial Scratch in Induction Ovulation Cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile Women with at Least 3 Failed of Ovulation Induction Cycles
Normal Semen Analysis
Between 15 and 40 Years Old Age
At Least 10 Antral Follicles
Normal Ultrasonography of Uterine
Exclusion criteria:
Endometrial Abnormality in Ultrasonography
Less than 10 Antral Follicles in Ultrasonography
Previous Abdominal Surgery
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bam University of Medical Sciences
Street address
Bam University of Medical Sciences, Khalije Fars Ave, Bam Town
City
Bam
Province
Kerman
Postal code
7661771967
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.MUBAM.REC.1400.043
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical Pregnancy Rate
Timepoint
2 Weeks After Missed Period
Method of measurement
Blood Beta HCG
Secondary outcomes
1
Description
Clinical Pregnancy Rate
Timepoint
3 Weeks After Positive Blood Beta HCG
Method of measurement
Ultrasonography
Intervention groups
1
Description
Intervention Group: In infertile women with at least three periods of unsuccessful ovulation induction, endometrial scratch is performed by the pipelle in the second half of the menstrual cycle on days 21-26, and the success rate of pregnancy in the next cycle is evaluated.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Bam Infertility Center
Full name of responsible person
Dr. Yasamin Mehrolhasani
Street address
Pasargad Clinic, Emam Khomeini St, Bam Town
City
Bam
Province
Kerman
Postal code
7661741733
Phone
+98 34 4431 5863
Email
yasamin_m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Dr Maziar Oveisi
Street address
Bam University of Medical Sciences, Khalije Fars Ave, Bam Town
City
Bam
Province
Kerman
Postal code
7661771967
Phone
+98 34 4434 1120
Fax
+98 34 4434 0847
Email
info@mubam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
Dr Yasamin Mehrolhasani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pastor Hospital, Hashemi Rafsanjani Blvd, Bam Town
City
Bam
Province
Kerman
Postal code
7661741733
Phone
0098444319404
Email
yasamin_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Dr Yasamin Mehrolhasani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bam University of Medical Sciences, Khalije Fars Blv, Bam Town
City
Bam
Province
Kerman
Postal code
7661741733
Phone
0098444319404
Email
yasamin_m@yahoo.ir
Person responsible for updating data
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Dr Yasamin Mehrolhasani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pastor Hospital, Hashemi Rafsanjani Blvd, Bam Town
City
Bam
Province
Kerman
Postal code
7661741733
Phone
+98 34 4434 9404
Email
yasamin_m@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