Determining the comparative effect of vaginal and oral administration of sildenafil on endometrialthickness in infertile women with thin endometrium in frozenembryo transfer cycles
Design
Randomized clinical trial will perform on 3 groups of infertile women, including a control group receiving sildenafil citrate only and two study groups receiving oral and vaginal sildenafil citrate. .
Settings and conduct
This study is about the treatment of female infertility and will perform double-blind at the Umm Al-Banin Infertility Treatment Center of Ganjavian Hospital.The study is a case-control study and will perform on 3groups of infertile women of childbearing age.The control group is only sildenafil and The case group received sildenafil vaginally and orally.
Participants/Inclusion and exclusion criteria
Entry requirements:
all patients will be contain Infertile women in the age range of 39-18 years
All women who have a frozen fetus and have been a history of a thin endometrium with routine medication preparation for endometriosis.
The condition of the fetus returned from the freezer should be of good quality (grade A, B)
Lack of drug sensitivity
No entry conditions:
History of endocrine disease: Diabetes, Hyperthyroidism, Hyperprolactinemia
Intervention groups
72 Infertile women were divided into three groups based on a random table and to prepare the endometrium, the first group would be given oral estradiol and the second and third groups, in addition to the estradiol treatment protocol, would be given oral and vaginal sildenafil citrate tablets, respectively. In all three groups, clinical monitoring will be performed serially every other day from the 11th day of menstruation to measure endometrial thickness.
Main outcome variables
amount of endometrial thickness, clinical pregnancy, chemical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050385N1
Registration date:2021-11-13, 1400/08/22
Registration timing:prospective
Last update:2021-11-13, 1400/08/22
Update count:0
Registration date
2021-11-13, 1400/08/22
Registrant information
Name
Mahdi Mohammadi nazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4235 8220
Email address
mahdinazari76@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of oral and vaginal sildenafil on endometrial thickness in infertile women with thin endometrium in frozen embryo transfer cycles
Public title
effect of sildenafil citrat on endometrial thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women between 39-18 years
All women who have a frozen fetus and have a history of a thin endometrium routinely prescribed medication to prepare the endometrium
The condition of the fetus returned from the freez should be have a good quality (grade A-B)
Lack of drug sensitivity
Exclusion criteria:
History of endocrine disease: Diabetes - Hyperthyroidism - Hyperprolactinemia
History of hysteroscopic surgery due to intrauterine adhesions
specific cardiovascular disease
History of stroke or myocardial infarction
serious hapeatofailure or renal failure
Alcohol abuse or substance abuse
Use of donated ovum
PCOS
endometriosis
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, sick people, ie infertile women, will be unaware of how the study groups are divided into two groups receiving placebo and the main drug, and also those who will perform the intervention in the clinic, ie researchers will be unaware from the distribution of study groups receiving placebo and The main drug
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of dezful university of medical sciences
Street address
Headquarters of Dezful University of Medical Sciences and Health Services, Corner of Justice Street., Post St., 15 Khordad Blvd., Dezful
City
dezful
Province
Khouzestan
Postal code
6461665145
Approval date
2021-04-03, 1400/01/14
Ethics committee reference number
IR.DUMS.REC.1400.007
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
clinical pregnancy
Timepoint
Three to four weeks after embryo transfer
Method of measurement
Presence of pregnancy sac in vaginal ultrasonography
2
Description
chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
serologic labratory result BHCG≥25
3
Description
endometrial thickness
Timepoint
From the eleventh day of the menstrual cycle serially every other day
Method of measurement
vaginal ultrasonography
Secondary outcomes
1
Description
Transmitted fetal quality
Timepoint
transmition day
Method of measurement
In terms of quality, it is divided into one of 3 groups A, B and C based on the number and size of embryonic cells (blastomers), increasing the pervasiveness and presence of multinucleated cells.
2
Description
implantation rate
Timepoint
Two weeks after embryo transfer
Method of measurement
beta-HCG examination
Intervention groups
1
Description
Intervention groupe 1:The second group, in addition to the estradiol treatment protocol, will be given oral sildenafil citrate tablets. Then, in the next stage of progesterone injection, 100 mg intramuscular for three to four days.
Category
Treatment - Drugs
2
Description
Intervention groupe 2: In the third group, in addition to the estradiol treatment protocol, sildenafil citrate tablets will be given to the vagina. Due to the unavailability of vaginal sildenafil, the patient is asked to moisten the oral sildenafil citrate tablet and place it in the vagina. 100 mg intramuscular for four days
Category
Treatment - Drugs
3
Description
Control groupe 1: The first group will receives only oral estradiol 3 times a day and then in the next stage of progesterone injection for three to four days at a rate of 100 mg intramuscular
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ganjavian Hospital, Dezful, Umm Al-Banin Infertility Center
Full name of responsible person
Sima jannati
Street address
Dezful-Andimeshk highway, Dezful, Khuzestan province
City
Dezful
Province
Khouzestan
Postal code
1111111111
Phone
+98 61 4242 2040
Email
mahdinazari76@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Dr.Sima jannati
Street address
Headquarters of Dezful University of Medical Sciences and Health Services, Corner of Justice St., Post St., 15 Khordad Blvd., Dezful -
City
dezful
Province
Khouzestan
Postal code
6461665145
Phone
+98 61 4242 8717
Email
info@Dums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul 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
Dezfoul University of Medical Sciences
Full name of responsible person
Dr.Sima jannati
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
corner of 15 Khordad Boulevard, Post Street
City
Dezful
Province
Khouzestan
Postal code
6478135860
Phone
+98 61 4235 8110
Email
sjanati@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Narges Majidipour
Position
instructure
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Corner of Justice Street, 15 Khordad Blvd., Post St.
City
Dezful
Province
Khouzestan
Postal code
6461665145
Phone
+98 61 4242 8203
Email
majidipour.n@dums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Mahdi Mohammadinazar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Mehr ST., Bahram town, Shush-e daniel,
City
shush
Province
Khouzestan
Postal code
6478135860
Phone
+98 61 4237 6455
Email
mahdinazari76@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