Determining the effect of Sildenafil and estradiol valerate on increasing endometrial thickness before intra uterine insemination
Design
A randomized, single blinded, controlled clinical trial with a parallel group design of 100 patients. Randomisation was carried out by Rand function of Microsoft Excel software
Settings and conduct
Patients referred to Alavi hospital of Ardabil with infertility due to decreased endometrial thickness are enrolled in to
one of the 2 groups of this study . Patients will be randomly assigned to one of the groupsand will be evaluated for treatment. Patients endometrial thickness will be evaluated by vaginal ultrasound after 9 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Patients with infertility due to a decreased endometrial thickness
2.Age between 20 to 35 years old
3.BMI lower than 30 kg per square meters
Exclusion criteria:
1.Women with congenital uterine abnormality or acquired deformity of uterine tube wich interferes with implantation
2.Women with tubal infertility
3.Women with contraindication to estrogen therapy (CVA or DVT history and benign hepatic diseases)
4.Women wich have a male factor infertility (Aospermia , Teratospermia, ...)
Intervention groups
Intervention group: An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10 days)+ Viagra vaginal gel 25 mg daily from day 9 to day 12
Control group: An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10 days)+ Placebo gel from days 9 to day 12
Main outcome variables
Endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210313050688N1
Registration date:2021-05-17, 1400/02/27
Registration timing:prospective
Last update:2021-05-17, 1400/02/27
Update count:0
Registration date
2021-05-17, 1400/02/27
Registrant information
Name
Faranak jalilvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 1206
Email address
f.jalilvand@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Sildenafil and estradiol valerate on increasing endometrial thickness before intra uterine insemination
Public title
ٍEffect of Sildenafil and estradiol valerate on increasing endometrial thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with infertility due to a decreased endometrial thickness
Age between 20 to 35 years old
BMI lower than 30 kg per square meters
Exclusion criteria:
Women with congenital uterine abnormality or acquired deformity of uterine tube wich interferes with implantation
Women with tubal infertility
Women with contraindication to estrogen therapy (CVA or DVT history and benign hepatic diseases)
Women wich have a male factor infertility (Aospermia , Teratospermia, ...)
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be enrolled randomly in to one of the groups based on inclusion criteria. Randomisation sequence will be processed by Microsoft Excel program via (RANDBETWEEN) command and numbers 0 and 1 will be allocated to each group to choose the group of the subject.
Blinding (investigator's opinion)
Single blinded
Blinding description
Viagra and placebo tablets are indistinguishable
for patients and can not be recognised by their
appearance
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Deputy of research and technology, Northern side of Ardabil university of medical sciences, Daneshgah sq., Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.ARUMS.REC.1399.571
Health conditions studied
1
Description of health condition studied
Female infertility due to nonimplantation of ovum
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Based on the reported sonographic result 9 days after initiation of treatment
Method of measurement
Transvaginal Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients of this group will receive An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10days) and also, they will receive Placebo gel vaginally from days 9 to 12 of the menstruation (up to 4 days). To evaluate endometrial thickness, patients will undergo vaginal sonography before initiation of treatment and 9 days after the treatment is completed.
Category
Placebo
2
Description
Intervention group: Patients of this group will receive An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10days) and also, they will receive Viagra gel vaginally from days 9 to 12 of the menstruation (up to 4 days). To evaluate endometrial thickness, patients will undergo vaginal sonography before initiation of treatment and 9 days after the treatment is completed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Dr Faranak Jalilvand
Street address
Maadi street, Saheli street
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3323 1206
Email
alavi@arums.ac.ir
Web page address
https://www.arums.ac.ir/alavi/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Farhad Pourfarzi
Street address
Deputy of research and technology, Northern side of Ardabil university of medical sciences, Daneshgah sq., Daneshgah st
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4776
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Faranak Jalilvand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi hospital, Maadi st., Saheli st.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
f.jalilvand@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Faranak Jalilvand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi hospital, Maadi st., Saheli st.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
f.jalilvand@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Faranak Jalilvand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi hospital, Maadi st., Saheli st.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 914 420 5288
Email
f.jalilvand@arums.ac.ir
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
Only data related to outcomes wil be shared
When the data will become available and for how long
Data will be accessible from 21 march 2022 onward
To whom data/document is available
Data will be accessible from 21 march 2021 onward
Under which criteria data/document could be used
No restrictions on data analysis after data is shared
From where data/document is obtainable
Dr Faranak Jalilvand
What processes are involved for a request to access data/document
All requests should be sent to the email address
f.jalilvand@arums.ac.ir and will be responded in 2
weeks time