In this double-blind randomized crossover clinical trial with a control group, the effects of sildenafil citrate on semen parameters will be examined in 84 patients 25 to 40 years old, with idiopathic infertility and normal erectile function referred to the Urology Clinic of Razi Hospital, Infertility Clinic of Al-Zahra Hospital and two private urology clinics in Rasht. First, a semen sample will be taken from all eligible persons. They will be asked not have to ejaculation 3 days before drug use and avoid smoking and caffeine use. And then by using the method of block randomization they will be randomized into one of the two groups of sildenafil citrate 50 mg and placebo recipients. Neither the participants nor the observers (researchers) know who will be placed in which group. One hour after treatment in both groups semen analysis again will be tested. After a washout period and spending the appropriate time for the next test which is defined one week, the two groups will be exchanged and semen analysis for the third time will be done one hour after taking the medicine. In this way during the study period all participants will receive once sildenafil citrate and once placebo.
Volume, acidity (pH), liquefaction, viscosity and appearance of each samples and concentration, count, vitality, motility and morphology of sperm will be evaluated along with demographic information and other clinical and laboratory data of patients will be collected in the questionnaire which is developed by researchers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611291853N12
Registration date:2017-02-10, 1395/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Survey of oral Sildenafil citrate and placebo effects on semen parameters in patients with idiopathic infertility
Public title
The effects of oral Sildenafil citrate on semen parameters
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Age range 25 to 40 years; normal erectile function; no history of acute febrile disease; no history of related drug use within 3 months before study
Exclusion criteria: Any factor that causes the testicles to get in contact with high temperatures includes long hot bath, sauna, bakery and other high-risk jobs; people with a history of seasonal allergies and sensitivities; consumption of alcohol, cocaine and certain medications, such as cimetidine, spironolactone, erythromycin, corticosteroids and methylxanthines such as theophylline, pentoxifylline and aminophylline and especially nitrates; history of testicular trauma or surgery; cardiovascular disease or high blood pressure and/or diabetes mellitus; consumption of hypertension drugs; consumption of drugs for the treatment of infertility
Age
From 25 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Randomization has been done by blocking or random block method in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite Sepah Bank, Western Shahid Beheshti Blvd., Gaz Square
City
Rasht
Postal code
41938-93345
Approval date
2015-07-10, 1394/04/19
Ethics committee reference number
IR.GUMS.REC.1394.79
Health conditions studied
1
Description of health condition studied
Idiopathic infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
2
Description of health condition studied
Erectile Dysfunction
ICD-10 code
F52.2
ICD-10 code description
Failure of genital response
Primary outcomes
1
Description
Ejaculation Volume
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
2
Description
Sperm Concentration
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
3
Description
Sperm Count
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
4
Description
Sperm Motility
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
5
Description
Sperm Vitality
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
6
Description
Sperm Morphology
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Sperm forward progression
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
2
Description
Appearance of Semen
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
3
Description
Sperm ph
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
4
Description
Semen viscosity
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
5
Description
Liquefaction
Timepoint
Before intervention and 3 days later, one hour after taking the drug or placebo and again a week later with an interval of one hour after drug or placebo (in general, it will be measured 3 times)
Method of measurement
Semen analysis
Intervention groups
1
Description
Intervention group: Sildenafil citrate 50 mg tablet, one dose, made in Iran
Category
Treatment - Drugs
2
Description
Control group: Placebo 50 mg tablet, one dose, made in Iran
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Soheil Kiyanfar (Resident of Urology)
Street address
Sardar Jangal Street, Razi Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Centre, Guilan University of Medical Sciences
Full name of responsible person
Head of Urology Research Centre, Dr. Siavsh Falahatkar
Street address
Sardar Jangal Street, Razi hospital, Urology Research Centre
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre, Guilan 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
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Soheil Kiyanfar
Position
Co worker/Resident of Urology
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Mokhtari
Position
Associated Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
gh.mokhtari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Research Expert/Master
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
4144895655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)