Effect of endometrial Scratching on pregnancy outcome after intrauterine insemination (IUI) in patients with previous IUI failure, a randomized clinical trial
Investigating the effect of endometrial scratching in improving the results of intrauterine sperm injection (IUI) in patients with repeated IUI failur
Design
A clinical trial with a control group, randomized, single-blind will be performed on 192 patients. The random sequence will be prepared using the website www.sealedenvelope.com software.
Settings and conduct
The number of 192 patients who are referred to the infertility clinic of Akbar Abadi Hospital with a history of at least two failed IUIs were randomly divided into two intervention groups (endometrial scratching ) and control group. Patients then undergo IUI. Finally, intrauterine pregnancy and live birth rates are compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile women with unspecified or male infertility aged between 20-42 years who have previously had at least two failed IUIs; Exclusion criteria: severe endometriosis, severe male factor infertility, underlying metabolic diseases
Intervention groups
Intervention group: patients who undergo endometrial scratching.
Control group: patients without endometrial scratching undergo vaginal examination simulating scratching.
Main outcome variables
Intrauterine pregnancy
Live birth rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200421047152N2
Registration date:2023-01-30, 1401/11/10
Registration timing:registered_while_recruiting
Last update:2023-01-30, 1401/11/10
Update count:0
Registration date
2023-01-30, 1401/11/10
Registrant information
Name
Arash Mohazzab
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2351 9630
Email address
amohazzab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of endometrial Scratching on pregnancy outcome after intrauterine insemination (IUI) in patients with previous IUI failure, a randomized clinical trial
Public title
Effect of endometrial Scratching on pregnancy outcome after intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-42 year
Unexplained infertility or mild male factor infertility
Failure of at least two previous intrauterine insemination (IUI) cycles
Exclusion criteria:
Presence of endometriosis in stage 3 and 4 diagnosed by ultrasound
Sever male factor infertility
Underlying metabolic disease (hyperprolactinemia, thyroid disorder or any known metabolic disease)
Ovarian follicle-stimulating hormone (FSH) level > 12
Body mass measurement > 30
Age
From 20 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization will be done according to age (above and below 35 years) and using permuted blocks with a size of 4. The random list is generated by the website www.sealedenvelope.com software and will be given to an independent third party for concealment and will be revealed to the researcher respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be aware of being in a study with two groups, with and without endometrial scraping, but will not know whether endometrial scraping is being performed for them. To reach this goal patients in the control group will undergo a vaginal examination with a speculum and a cervical scraper will enter into the posterior fornix without scratching. Patients in the control group will not be informed about the intervention type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IUMS Biomedical Research Ethics Committee
Street address
Next to Milad Tower ,Hemat Highway
City
Tehran
Province
Tehran
Postal code
1134845764
Approval date
2023-01-11, 1401/10/21
Ethics committee reference number
IR.IUMS.REC.1401.833
Health conditions studied
1
Description of health condition studied
Infertility needs intrauterine insemination (IUI)
ICD-10 code
Z31.1
ICD-10 code description
Artificial insemination
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
5-6 weeks after IUI
Method of measurement
Transvaginal sonography
Secondary outcomes
1
Description
Live birth rate
Timepoint
28 weeks of pregnancy
Method of measurement
Phone based interview
2
Description
Chemical pregnancy rate
Timepoint
14 days after IUI
Method of measurement
Measurement of beta human chorionic gonadotropin serum level (Beta HCG)
Intervention groups
1
Description
Endometrial scratching intervention group: Endometrial scratching is done in the intrauterine sperm injection (IUI) cycle on day 5 or 6 from the beginning of the menstrual cycle. To perform endometrial scratching, the patient is placed in a lithotomy position. Then, the speculum is slowly placed in the vagina to expose the cervix, and with the use of a flexible catheter, the endometrium is scratched in a circular position after performing aspiration. The circular movement of the catheter starts and ends in 12 o'clock position, and then the catheter is removed. If the catheter does not pass through the tenaculum, the anterior edge of the cervix is used to grasp the. According to the level of Anti-Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours.
Category
Treatment - Surgery
2
Description
Control group: Patients in this group will undergo a vaginal examination with a speculum and a cervical scraper will enter into the posterior fornix without scratching. According to the level of Anti-Müllerian Hormone (AMH) and Ovarian Reserve Count (AFC), letrozole, Cinnal F, or Menstrual Gonadotropin (HMG) is used to stimulate the ovaries, depending on the initial response to stimulation. After starting the drugs, the follicle size is monitored. When the size of the follicles is greater than or equal to 18, two ampoules of human chorionic gonadotropin (HCG) are prescribed to release the egg, and the patient undergoes IUI after 36 hours.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Mahnaz Ashrafi
Street address
Bagh-ferdous station, Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 86709
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 8670 1021
Email
Keyvanlab@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Behnaz Mohabatian
Position
Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bagh-ferdous station, Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 86709
Email
dr.mohabatian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Ashrafi
Position
Professor in infertilty
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bagh-ferdous station, Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 86709
Email
ashrafi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arash Mohazzab
Position
Ph.D cadidate
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Next to Milad Tower ,Hemat Highway
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 8670 1021
Email
amohazzab@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