My objective is to test the Effect of thiamine tablet ( B 1) on general health and treatment success in infertile women with polycystic ovary syndrome . 64 women who have polycystic ovary syndrome will be randomly divided into 2 group. After completing the data for each patient blood samples taken at this stage and b-HCG hormone tests and the number of oocytes and their status will be determined. One of them will use 300mg tab tiamin . the other group will use placebo tablet daily. After the treatment period, again from all the people who are excluded from the study is not the General Health Questionnaire (GHQ) will be completed for evaluation indicators of treatment success (the number of follicles, the quality of follicles, number of oocytes) and a test of B-HCG as the positive therapeutic response will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510266917N3
Registration date:2016-05-01, 1395/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
l-amini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- nursing and midwifery school, Iran University of Medical Science
2- sarem specialized hospital of gynecology
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of thiamine tablet ( B 1) on general health and treatment success in infertile women with polycystic ovary syndrom
Public title
Effect of thiamine tablet ( B 1) on general health and treatment success in infertile women with polycystic ovary syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with PCOs according to Rotterdam criteria; age 18-40 years
be agree with study; not use alcohol; non usage psychological drugs; non addict or a history of addiction; without basic illness ; non usage of B1 last month; not using complimentary drug last month; at-last 3 period treatment of infertility
exclusion criteria: not agree with continue the study; appears allergic symptoms; incorrect drug usage; discontinue treatment of infertility
Age
From 76 years old to 54 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized study using Blocking.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical Science
Street address
Tehran, Hemat high way, Iran University of medical science
City
Tehran
Postal code
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
IR.IUMS.RREC.1394_26840
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrom
ICD-10 code
E28.2
ICD-10 code description
2
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Primary outcomes
1
Description
General health
Timepoint
before and after of intervention
Method of measurement
standard questionarey
2
Description
Success treatment
Timepoint
before and after of intervention
Method of measurement
positive pregnancy test
Secondary outcomes
1
Description
B-HCG
Timepoint
Before and after of experiment
Method of measurement
hormone assay
Intervention groups
1
Description
Intervention group: treated with 300 mg vitamin B1 tablets product HAKIM Pharmaceutical Company once in the morning for a period of 4 weeks during experimental
Category
Treatment - Drugs
2
Description
product Control group: treated with placebo tablets 300 mg product HAKIM Pharmaceutical Company during experimental
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
sarem hospital
Full name of responsible person
Mahtab Moti
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chencelor for research, Iran Nursing and Midwifry School, Iran University of Medical Science
Full name of responsible person
masoumeh abdoli
Street address
Hemat St.
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chencelor for research, Iran Nursing and Midwifry School, Iran University of Medical Science
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
Iran Nursing and Midwifry School
Full name of responsible person
mahtab moti
Position
MSc student
Other areas of specialty/work
Street address
Valiasr street
City
Tehran
Postal code
Phone
+98 21 8820 8159
Fax
Email
mahtab_moti@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Nursin and Midwifery School
Full name of responsible person
Leila Amini
Position
PhD candidate
Other areas of specialty/work
Street address
Valiasr street
City
Tehran
Postal code
Phone
+98 21 8820 8159
Fax
Email
l-amini@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran Nursin and Midwifery School
Full name of responsible person
mahtab moti
Position
MSc
Other areas of specialty/work
Street address
Valieasr street -
City
Tehran
Postal code
Phone
00
Fax
Email
mahtab_moti@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)