120 cases of patients with mail infertility who will be detected by semen fluid analysis on the basis of WHO criteria and also are candidate for IUI will be studied. 60 cases will be in control group and another 60 cases in the case group. Pharmacist physician will make an encode packages containing 400IU vitamin E and placebo quit similar to each other so that they will be indistinguishable to both executive and the patients. Patients will recieve encoded packages on the basis of the order based on the plan table offered by the pharmacologist. Each patient will recieve the package content for two months and the sperm analysis and after that the routine steps of IUI will be done. And information will be embeded in the questionaire after collecting data. Then the codes of the packages will be broken and statistical analysis will be done between the case and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122815961N1
Registration date:2014-04-24, 1393/02/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-24, 1393/02/04
Registrant information
Name
faranak fatehpour
Name of organization / entity
shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1227 9715
Email address
fatehpoorf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences- Vice Chancellor for research
Expected recruitment start date
2014-05-01, 1393/02/11
Expected recruitment end date
2016-12-27, 1395/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assess of effect of oral vitamin E on increase of intra uterine inseminization success in infertile men
Public title
assess of effect of oral vitamin E on increase of intra uterine inseminization success in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Sperm count less than or equal to 15000000 CC ؛ progressive motility less than or equal to 32%؛ normal shaped sperm less than or equal to 4% according to WHO 2011 criteria for male infertility ؛ doing IUI for the first time
Exclusion criteria : not willing to cooperate in the project ؛ not willing to use vitamin E for any reason ؛ showing sensitivity to vitamin E
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences- Vice Chancellor for research
Street address
Iran- Fars- Shiraz- Zand street- Central department- Shiraz University of Medical Sciences- Vice Chancellor for research
City
Shiraz
Postal code
Approval date
2013-12-18, 1392/09/27
Ethics committee reference number
CT-P-92-5605
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm counts
Timepoint
After two mounts of treatment
Method of measurement
Semen analysis
2
Description
sperm motility
Timepoint
After two mounts of treatment
Method of measurement
Semen analysis
3
Description
percentage of normal shape sperm
Timepoint
After two mounts of treatment
Method of measurement
Semen analysis
Secondary outcomes
1
Description
clinical pregnancy rate
Timepoint
6-8 weeks after IVF
Method of measurement
By follow up of the patients and sonography
2
Description
chemical pregnancy rate
Timepoint
16-18 days after IVF
Method of measurement
By measurement of B-HCG
Intervention groups
1
Description
Interventiion: 400 IU Vit E will be given orally to 60 infertile men for two months before IUI.
Category
Treatment - Drugs
2
Description
control:Similar shape placebo will be given orally to 60 infertile men two months before IUI.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother & Child Hospital, infertility ward
Full name of responsible person
faranak Fatehpour
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences- Vice Chancellor for research
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Iran- Fars- Shiraz- Zand street- Central department- Shiraz University of Medical Sciences- Vice Chancellor for research
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences- Vice Chancellor for research
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
Shiraz University Of Medical Scienses
Full name of responsible person
Faranak Fatehpour
Position
Extern
Other areas of specialty/work
Street address
Iran, Shiraz, Shahid Faghihi Hospital, Department of OB-GYN
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
Email
fatehpoorf@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Bahia Namavar Jahromi
Position
Professor
Other areas of specialty/work
Street address
Department of OB-GYN, Shahid Faghihi Hospital, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
Email
namavarb@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Scienses
Full name of responsible person
Faranak Fatehpour
Position
extern
Other areas of specialty/work
Street address
Iran, Shiraz, Shahid Faghihi Hospital, Department of OB-GYN
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
+98 71 1227 9715
Email
fatehpoorf@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)