120 of the patients who have been candidated for IVF, due to male infertility, in Infertility center of Ghadir Mother and Child Hospital will be studied. 60 of those people will be placed in case group and the other 60 will be placed in control group. Pharmacist Physician will prepare and encode the pharmacy package, contains 400IU of vitamin E and placebo identically, such away that its appearance is quite similar and look indistinguishable for the executive and patients.
Patients will recieve the pharmacy package coded from the pharmacologist; according to the table given by pharmacologists,depending on their enterance time to the project. Each patient will use the pharmacy package for two months and then th sperm analysis will be performed. Then, the IVF procedures will be done and the data will be recorded in the questionaires attached and will be stored in SPSS software. After gathering data and entering it in the system, the codes will be broken and statistical analysis will be performed between the Case and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020616506N1
Registration date:2014-03-18, 1392/12/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-18, 1392/12/27
Registrant information
Name
Niloofar Borzou
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1227 9715
Email address
borzou@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 In Vitro Fertilization success in infertile men
Public title
Assess of effect of oral vitamin E on increase of In Vitro Fertilization success in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion conditions:
120 of the patients who have been candidated for IVF due to male infertility, have been diagnosed through the semen analysis upon WHO’s criteria and have satisfied the conditions of performing IVF based on existing criteria ( i.e. after semen processing, it contains less than 1-2 million motile sperms, or less than 10 million motile sperms in addition to more than 2 years infertility without any response to IUI ) will be studied.
Exclusion conditions:
If people are not willing to cooperate in the project or consuming vitamin E, for any reason and also show any sensitivity to vitamin E, will be excluded from the project.
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:
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
2013-12-24, 1392/10/03
Ethics committee reference number
CT-P-92-5604
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Oligospermia NOS
Primary outcomes
1
Description
Comparison of sperm counts
Timepoint
After two mounts of treatment
Method of measurement
Semen analysis
2
Description
Comparison of sperm motility
Timepoint
After two mounts of treatment
Method of measurement
Semen analysis
3
Description
Comparison of the percentage of normal shape sperm
Timepoint
After two mounts of treatment
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Comparison of clinical pregnancy rate
Timepoint
6-8 weeks after IVF
Method of measurement
By follow up of the patients and sonography
2
Description
Comparison of chemical pregnancy rate
Timepoint
16-18 days after IVF
Method of measurement
By measurement of B-HCG
Intervention groups
1
Description
Interventiion group: 400 IU Vit E will be given orally to 60 infertile men for two months before IVF.
Category
Treatment - Drugs
2
Description
Control group: similar shape placebo will be given orally to 60 infertile men two months before IVF.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother & Child Hospital, infertility ward
Full name of responsible person
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
Niloofar Borzou
Position
Extern, Medical student
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
borzou@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
Niloofar Borzou
Position
Extern, Medial student
Other areas of specialty/work
Street address
Iran- Shiraz-Faghihi Hospital-Department of OB-GYN
City
Shiraz
Postal code
Phone
+98 71 1227 9715
Fax
+98 71 1227 9715
Email
Borzou@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)