Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of selenium supplementation on gene expression related to inflammation in patients with polycystic ovary syndrome candidate for IVF
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Design
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Study 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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Among patients with polycystic ovary syndrome candidate for IVF referred to Mahdieh Clinic affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criteria: Metabolic abnormalities such as diabetes, impaired glucose tolerance and thyroid dysfunction.
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Intervention groups
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Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 8 weeks orally.
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Main outcome variables
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Outcomes: Expressed levels of TNF-a gene (primary outcome) and gene expression related to other inflammatory factors (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:
IRCT20170513033941N23
Registration date:
2017-12-20, 1396/09/29
Registration timing:
registered_while_recruiting
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-12-20, 1396/09/29
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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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Expected recruitment start date
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2017-12-11, 1396/09/20
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Expected recruitment end date
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2017-12-30, 1396/10/09
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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 inflammation in women with polycystic ovary syndrome candidate for IVF.
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Public title
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Effect of selenium supplementation in the treatment of women with polycystic ovary syndrome candidate for IVF.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with polycystic ovary syndrome.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Metabolic abnormalities such as diabetes, impaired glucose tolerance and thyroid dysfunction
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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 (<25 and ≥25 kg/m2) and age (<30 and ≥30 y), subjects will be randomly divided into two groups to receive supplement or placebo. 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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2017-12-10, 1396/09/19
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1396.737
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 TNF-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
Secondary outcomes
1
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Description
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Expressed levels of IL-1 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 IL-8 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
3
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Description
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Expressed levels of VEGF
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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
4
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Description
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Expressed levels of TGF-B
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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 (Barij Essence, Kashan, Iran), daily, for 8 weeks orally.
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Category
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Placebo
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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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