Evaluation of the effect of endometrial thickness in the luteal phase on the final outcome of pregnancy in intrauterine insemination
Design
The intervention will be done before and after and all patients will receive the intervention.
Settings and conduct
The present study will be conducted in the form of a before and after study. In this study, all unbelieving women in the age range of 20 to 40 years, who refer to Akbar Abadi Women's Hospital affiliated to Iran University of Medical Sciences between June2024 and October 2024 and meet the entry criteria, will be included in the study. During the cycle, the thickness of the endometrium is evaluated using transvaginal ultrasound. After the follicle size reaches above 17mm, the trigger injection day is determined. On the trigger day, the endometrium is measured, which is measured at a distance of one centimeter below the fundus from the outermost part of the thickness on both sides, about 34 to 36 hours after the IUI trigger. One week after intrauterine insemination, the thickness of the endometrium is measured again.
Participants/Inclusion and exclusion criteria
Entry criteria include: women with definite diagnosis of infertility (absence of pregnancy in couples who had regularly tried to get pregnant within 12 months) and women with an age range of 20 to 40 years. The exclusion criteria of the study included women with uterine abnormalities such as uterine septum, endometrial polyp, submucous myoma, and women who had a history of hysteroscopic surgery.
Intervention groups
This before and after trial study will be conducted on women with a definite diagnosis of infertility in the age range of 20 to 40 years. All patients receive a dose of Human chorionic gonadotropin as an endometrial trigger in the follicular phase and one week before intrauterine insemination.
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062356N1
Registration date:2024-08-20, 1403/05/30
Registration timing:registered_while_recruiting
Last update:2024-08-20, 1403/05/30
Update count:0
Registration date
2024-08-20, 1403/05/30
Registrant information
Name
Masoomeh Behi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3357 0037
Email address
masoomehbehi8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-26, 1403/05/05
Expected recruitment end date
2024-09-26, 1403/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of endometrial compression in the luteal phase on pregnancy outcomes in the intrauterine insemination
Public title
The effect of endometrial compression in the luteal phase on pregnancy outcomes in the intrauterine insemination
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of infertility (absence of pregnancy in couples who had regularly taken pregnancy tests within 12 months)•
age range of 20 to 40 years
Exclusion criteria:
Having uterine abnormalities such as uterine septum, endometrial polyps, submucosal myoma.
History of hysteroscopic surgery
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
93
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 Iran University of Medical Sciences
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.IUMS.FMD.REC.1403.189
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy based on beta HCG test
Timepoint
And a week later artificial insemination of endometrial thickness. Two weeks after artificial insemination, all patients are evaluated for pregnancy with a beta HCG test with a blood sample.
Method of measurement
All patients are evaluated for pregnancy with a beta HCG test with a blood sample.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All infertile women will receive a dose of human chorionic gonadotropin (hCG) as an endometrial trigger on the day of a follicular cycle. About 34 to 36 hours after the administration of the trigger, artificial insemination of the uterus (IUI) is performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital, Tehran
Full name of responsible person
Masoomeh Behi
Street address
Tehran Province, Tehran, Molvi St., Ferdous Bagh Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Iran university of medical sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
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
Mojgan Javedani Masroor
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Province, Tehran, Molvi St., Ferdous Bagh Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
masoomehbehi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojgan Javedani Masroor
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Province, Tehran, Molvi St., Ferdous Bagh Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
masroor.j@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Behi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran Province, Tehran, Molvi St., Ferdous Bagh Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
masoomehbehi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All demographic data and primary and secondary outcome information after de-identification of shareable subjects
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Data and other documentation will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
After publishing the results in the form of an article, the data will be available for researchers to design the study by providing a logical reason to the correspondence author with the condition of maintaining ethical principles. Also, the data will be available if requested by the ethics committee of the university to evaluate the accuracy of the results.
From where data/document is obtainable
To receive the required documents and data, applicants can contact Dr. Masoumeh Behi, Obstetrics and Gynecology Assistant, Iran University of Medical Sciences, address: Tehran, Molvi Street, Bagh Ferdous Station, Akbar Abadi Hospital, and email: masoomehbehi@gmail.com
What processes are involved for a request to access data/document
Applicants must follow the protocols and procedures according to Shahid Beheshti University of Medical Sciences rules to access the desired files.