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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Protocol summary
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=25) or placebo (n=25).
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).
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=2520) or placebo (n=2520).
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل سلنیوم (25=n) یا پلاسبو (25=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل سلنیوم (20=n) یا پلاسبو (20=n) اختصاص داده خواهند شد.
طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل سلنیوم (2520=n) یا پلاسبو (2520=n) اختصاص داده خواهند شد.
Among patients with polycystic ovary syndrome candidate for IVF referred to Mahdieh Clinic affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran, 50 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.
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.
Among patients with polycystic ovary syndrome candidate for IVF referred to Mahdieh Clinic affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran, 5040 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.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF ارجاع شده به کلینیک مهدیه وابسته به دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران، 50 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF ارجاع شده به کلینیک مهدیه وابسته به دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران، 40 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
از بین بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF ارجاع شده به کلینیک مهدیه وابسته به دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران، 5040 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 8 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
Inclusion criteria: Patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
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.
Inclusion criteria: Patients with polycystic ovary syndrome candidate for IVF aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperateMetabolic abnormalities such as diabetes, impaired glucose tolerance and thyroid dysfunction.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاری.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: اختلالات متابولیک از قبیل دیابت، اختلال در تحمل گلوکز و اختلال در عملکرد تیروئید.
معیار ورود به مطالعه: بیماران مبتلا به سندروم تخمدان پلی کیستیک کاندید IVF در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: عدم تمایل به همکاریاختلالات متابولیک از قبیل دیابت، اختلال در تحمل گلوکز و اختلال در عملکرد تیروئید.
General information
2
3
23
50
40
5040
2017-12-26, 1396/10/05
2017-12-30, 1396/10/09
2017-12-2630 00:00:00
Exclusion criteria: Unwillingness to cooperate.
Exclusion criteria: Metabolic abnormalities such as diabetes, impaired glucose tolerance and thyroid dysfunction
Exclusion criteria: Unwillingness to cooperate.Metabolic abnormalities such as diabetes, impaired glucose tolerance and thyroid dysfunction
معیار خروج از مطالعه: عدم تمایل به همکاری.
معیار خروج از مطالعه: اختلالات متابولیک از قبیل دیابت، اختلال در تحمل گلوکز و اختلال در عملکرد تیروئید
معیار خروج از مطالعه: عدم تمایل به همکاری.اختلالات متابولیک از قبیل دیابت، اختلال در تحمل گلوکز و اختلال در عملکرد تیروئید
Sponsors / Funding sources
#1
Shahid beheshti University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Shahid beheshtiBeheshti University of Medical Sciences
Sharing plan
empty
Undecided - It is not yet known if there will be a plan to make this available.
Undecided - It is not yet known if there will be a plan to make this available.
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست.
Protocol summary
Study aim
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
Design
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).
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
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
Registration date
2017-12-20, 1396/09/29
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2017-12-30, 1396/10/09
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 inflammation in women with polycystic ovary syndrome candidate for IVF.
Public title
Effect of selenium supplementation in the treatment of women with polycystic ovary syndrome candidate for IVF.
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.737
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 TNF-a gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
Secondary outcomes
1
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
2
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
3
Description
Expressed levels of VEGF
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
PCR
4
Description
Expressed levels of TGF-B
Timepoint
At the beginning of the study and after 8 weeks of intervention