Protocol summary
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Study aim
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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.
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Design
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Design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive selenium supplements (n=20) or placebo (n=20).
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Settings and conduct
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Population and sample size: Among patients with polycystic ovary syndrome referred to Mahdieh Clinic affiliated to Shahid Beheshti University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS of IVF candidate according to Rotterdam criteria and aged 18 to 40 years will be included in this study. Exclusion criteria: Pregnant women Participants with elevated levels of prolactin Thyroid disorder Endocrine diseases.
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Intervention groups
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Intervention: Patients will be assigned into two groups to receive selenium (n=20) or placebo (n=20). Selenium and placebos capsules are similar in shape and size. At the beginning and end of the intervention: 8 weeks.
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Main outcome variables
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Gene expression of PPAR-γ and glucose transporter 1 (GLUT-1) (primary outcomes) and gene expression levels of low-density lipoprotein receptor (LDLR) and lipoprotein(a) [LP(a)] (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201704245623N113
Registration date:
2017-05-06, 1396/02/16
Registration timing:
retrospective
Last update:
2019-09-19, 1398/06/28
Update count:
1
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Registration date
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2017-05-06, 1396/02/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2016-04-16, 1395/01/28
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Expected recruitment end date
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2016-05-09, 1395/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of supplementation in treatment of women with polycystic ovary syndrome of IVF candidate
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with PCOS of IVF candidate according to Rotterdam criteria
Aged 18 to 40 years
Exclusion criteria:
Pregnant women
Participants with elevated levels of prolactin
Thyroid disorder
Endocrine diseases
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either selenium supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-04-15, 1395/01/27
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Ethics committee reference number
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IR.SBMU.REC.1396.33
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Expressed levels of PPAR-γ
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of GLUT-1
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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PCR
Secondary outcomes
1
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Description
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Expressed levels of Lp(a) gene
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of LDLR gene
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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PCR
Intervention groups
1
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Description
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Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 8 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule, daily for 8 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available