Comparison of the effect of ethinyl estradiol with sildenafil citrate versus ethinyl estradiol on endometrial thickness in infertile women: a randomized clinical trial
Objectives: To assess the effect of ethinyl estradiol with sildenafil citrate versus ethinyl estradiol on endometrial thickness in infertile women.
Design: A randomized clinical trial.
Setting and conduct: The eligible infertile women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 40 years; male factor Infertility; no response to ovulation induction and intrauterine inoculation of semen.
Exclusion criteria: Hydrosalpinx in one or both tubes; smoker; absence of at least two reached follicles following treatment; absence of fetus or at least one fetus.
Intervention group: Vaginal ethinyl estradiol 5 mg 4 times a day plus vaginal sildenafil citrate 25 mg 4 times a day for 2 weeks.
Control group: Vaginal ethinyl estradiol 5 mg 4 times a day for 2 weeks.
Primary outcome: Assessing the endometrial thickness one and two weeks after treatment using transvaginal sonography.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704119014N156
Registration date:2017-04-12, 1396/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-21, 1396/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ethinyl estradiol with sildenafil citrate versus ethinyl estradiol on endometrial thickness in infertile women: a randomized clinical trial
Public title
Comparison of the effect of ethinyl estradiol with sildenafil citrate versus ethinyl estradiol on endometrial thickness in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 40 years; male factor Infertility; no response to ovulation induction and intrauterine inoculation of semen.
Exclusion criteria: Hydrosalpinx in one or both tubes; smoker; absence of at least two reached follicles following treatment; absence of fetus or at least one fetus.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2007-04-08, 1386/01/19
Ethics committee reference number
IR.UMSHA.REC.1396.35
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
Assessing the endometrial thickness
Timepoint
one and two weeks after treatment
Method of measurement
using transvaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vaginal ethinyl estradiol 5 mg 4 times a day plus vaginal sildenafil citrate 25 mg 4 times a day for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: Vaginal ethinyl estradiol 5 mg 4 times a day for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Artimis Sadeghian
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Artimis Sadeghian
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
art_sadeghian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Artimis Sadeghian
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
art_sadeghian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)