The overall objective: Evaluation of the effect of vitamin E on quality of emberyo and ovum in invitro fertilization in unxpainend infertility Specific goals: - Compare motility of sperm in semen analysis before and after vitamin E in two groups of case and control-- Compare normal shape of sperm in semen analysis before and after vitamin E in two groups of case and control-- Compare count of sperm in semen analysis before and after vitamin E in two groups of case and control-- Compare Total Motile Sperm Count of sperm in semen analysis before and after vitamin E in two groups of case and control -- Effect of vitaminE in number of ovum in IVF-Effect of vitaminE in quality of ovum in IVF-Effect of vitaminE in number of emberyo in IVF-Effect of vitaminE in quality of emberyo in IVF-- Compare the people with positive Human Chorionic Gonadotropine in case and control groups-- Compare the people with positive Fetal heart rate in case and control groups- Materials and methods: 120 couple of patient with unexplained infertility(normal semen analasys and normal ovulation and normal tubes and endometrial cavity )that candidate for IVF in Madar koodak clinic of infertility of Ghadir came to our study.according to consult with statistic the patient divided to two groups 60 patient forcase and 60 patient for control. Drug (400 mg vitaminE)and placebo prepare by pharmacologist with the same shape.and the patient have the pakage of drug due to number of coming to study drugs melatonin or placebo have the same packages and special code.each person including the study such as gynecologist ,resident or staff of infertility clinic do not know each pocket is viamin E or placebo and our study is completely double-blind.the patient eat drug or placebo 2 month and IVF was done and semen analasis repeat ,data complete in proposal and then code of drug pockets will be opened.and two group compare with each other
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405286541N4
Registration date:2014-07-14, 1393/04/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-14, 1393/04/23
Registrant information
Name
Bahia Namavar Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
namavarb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Science
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamine E in a couple with unexplained infertility on embryo quality and outcome of IVF
Public title
Effect of vitamin E in out come of IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
Normal semen sample ؛
Normal Hystrosalpin geography ؛
Normal ovulation؛
IVF For ferst time ؛
Long protocole؛
Befor 39 years old ؛
Inclusion criteria:
No desire for cooperation ؛
Sensivity to Vitamin E ؛
≥ 39 year old ؛
Age
From 18 years old to 39 years old
Gender
Both
Phase
2
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
Medical Science Researching، Shiraz Univercity of Medical Science
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Postal code
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
CT-P-92-5856
Health conditions studied
1
Description of health condition studied
- Unexplained infertility
ICD-10 code
N97.9
ICD-10 code description
Female Iinfertility, Unspecified
Primary outcomes
1
Description
- Quality and number of ovum and emberyo have received in each IVF cycle
Timepoint
- On day of ovum pick up and emberyo insercion (IVF)
Method of measurement
- Measuring number and quality of ovumes on the day of pick up in lab by pathologist under microscope (GV , MI , MII ) and quality of emberyo also by the same pathologist due to kind of cell division ( Grade I , II , III , IV)
Secondary outcomes
1
Description
Clinical pregnancy or misscariage
Timepoint
4 – 6 weeks after emberyo transfering
Method of measurement
Serum BHCG and TVS
Intervention groups
1
Description
In The Main Group The paitents eats one ca of vitaminE or placebo (400mg) one per day from the day of base sono till 2 month
Category
Treatment - Drugs
2
Description
In The control group The Patients eats one ca of vitaminE or placebo (400mg) one per day from the day of base sono till 2 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother & Child Hospital،Shiraz
Full name of responsible person
Dr Zahra Mosallanezhad
Street address
Shiraz University of Medical Sciences ، Zand Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
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
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 Sciences
Full name of responsible person
Dr Zahra Mosallanezhad
Position
Resident Of GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences ، Zand Street