Clinical trial of the effect of selenium supplementation compared with the placebo on gene expression related to insulin and lipid in women with polycystic ovary syndrome of IVF candidate
Objective: The aim of this study is to determine the effects of selenium supplementation on gene expression related to insulin and lipid in patients of polycystic ovary syndrome of IVF candidate. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with polycystic ovary syndrome referred to Mahdieh Clinic affiliated to Shahid Beheshti University of Medical Sciences, 50 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive selenium (n=25) or placebo (n=25). Selenium and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and end of the intervention: 8 weeks. Outcomes: Gene expression related to insulin (primary outcomes) and gene expression related to lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704245623N113
Registration date:2017-05-06, 1396/02/16
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-16, 1395/01/28
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of selenium supplementation compared with the placebo on gene expression related to insulin and lipid in women with polycystic ovary syndrome of IVF candidate
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome of IVF candidate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome of IVF candidate; aged 18 to 40 years.
Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak
City
Tehran
Postal code
Approval date
2016-04-15, 1395/01/27
Ethics committee reference number
IR.SBMU.REC.1396.33
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Expressed levels of PPAR-γ
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of GLUT-1
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of Lp(a) gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of ox-LDL gene
Timepoint
At the beginning of the study and after 8 weeks of intervention