Evaluation of the effect of vaginal sildenafil on endometrial thickness and fertility in infertile women IUI candidates referred to infertility clinic of Shahid Beheshti Hospital in Kashan in 2020
Design
Clinical trial with control group, with parallel, randomized, phase 3 groups on 60 patients. The card shuffle method was used for randomization.
Settings and conduct
This clinical trial study will be performed on 60 infertile women IUI candidates referred to the infertility clinic of Shahid Beheshti Hospital in 2016.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All women under the age of 40 are candidates for IUI for the first time up to the third maximum, with a sperm count of 10-10 million, a motility of 25-30%, a normal morphology of 3-4%, and a BMI of less than 40.
Exclusion criteria:
Hypotension, history of endocrine diseases, history of stroke or heart attack, cardiovascular, renal and hepatic problems, use of nitrites or nitrates
Intervention groups
The subjects were randomly divided into two groups of 30 people receiving sildenafil and estradiol (experimental group) and the group receiving estradiol (control group). In the experimental group, a 25 mg sildenafil vaginal tablet and an oral estradiol 2 mg tablet are administered every 12 hours every 12 hours, and in the control group, a 2 mg estradiol tablet is administered every 12 hours until the day of injection, and the endometrial thickness is repeated daily. IUI is measured. Two weeks after IUI, a pregnancy test will be done with a Beta HCG blood test.
Main outcome variables
Endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049997N1
Registration date:2021-06-04, 1400/03/14
Registration timing:registered_while_recruiting
Last update:2021-06-04, 1400/03/14
Update count:0
Registration date
2021-06-04, 1400/03/14
Registrant information
Name
niloofar mehry
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
niloofar.mehry.1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-16, 1399/12/26
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vaginal sildenafil on endometrial thickness and pregnancy rates in infertile women undergoing intrauterine insemination
Public title
The effect of vaginal sildenafil on endometrial thickness and pregnancy rates in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The number of sperm in female spouses is between 5-10 million.
Sperm motility of female spouses should be between 25-30%.
The normal morphology of female spouses sperm is between 3-4%.
Women's body mass index should be less than 40.
Endometrial thickness less than 7 mm.
Exclusion criteria:
Hypotension
History of endocrine diseases
History of stroke or heart attack
Cardiovascular problems
Consumption of nitrites or nitrates
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomly divided into two groups of 30 people receiving sildenafil and estradiol (experimental group) and the group receiving estradiol (control group). In this method, a number of cards selected by the researcher as the first group and the same number of cards for the next groups are considered; Then, by merging the cards together (flipping the cards), a card is taken out and its allocation is recorded, and that card is returned to the other cards after being taken out. The cards are then merged again and another card is removed. This process continues until a random sequence according to the sample size is reached.
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
Faculty of Medicine and Dentistry - Kashan University of Medical Sciences
Street address
Kashan-Qutb Ravandi Boulevard-Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.101
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Measurement of endometrial thickness at the beginning of the study (before the start of the intervention, which should be less than 7 mm) and 14 days after the start of taking an oral estradiol tablet and a sildenafil vaginal tablet
Method of measurement
Ultrasound device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sildenafil and estradiol, made in Iran and Marham Daroo Company, a vaginal tablet of sildenafil 25 mg and an oral tablet of estradiol 2 mg every 12 hours are prescribed every 6 hours.
Category
Treatment - Drugs
2
Description
Control group: Estradiol 2 mg tablets are given every 12 hours until the day of HCG (human chorionic gonadotropin) injection.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Research Assistant
Street address
Qutb Ravandi Blvd., Parstar Blvd., Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5550 0111
Email
ResearchAssistant@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zohre Tabasi
Street address
Qutb Ravandi Blvd., Parstar Blvd., Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
drtabasiz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Niloofar Mehry
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 32, 24 metri taro pood alley, elahie Blvd, Kashan Town
City
Kashan
Province
Isfehan
Postal code
8719860004
Phone
+98 31 5554 0026
Fax
Email
niloofar.mehry.1988@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Niloofar Mehry
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 32, 24 metri taro pood alley, elahie Blvd, Kashan Town
City
Kashan
Province
Isfehan
Postal code
8719860004
Phone
+98 31 5554 0026
Fax
Email
niloofar.mehry.1988@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Niloofar Mehry
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 32, 24 metri taro pood alley, elahie Blvd, Kashan Town
City
Kashan
Province
Isfehan
Postal code
8719860004
Phone
+98 31 5554 0026
Fax
Email
niloofar.mehry.1988@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
Not applicable
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
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access period starts from 1400
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Request in writing and signed by mail
From where data/document is obtainable
Mainly responsible for the study
What processes are involved for a request to access data/document