This is a non-randomized clinical trial, controlled with metformin, wich deisign toEvaluating the changes in outcome and serum metabolic biochemical parameters after oral Simvastatin administration in patients with poly cystic ovary syndrome. All patients in reproductive age with pcos that refer to infertility clinic of Fatemieh hospital of Hamadan, and without history of endocrine disease, Recent use of lipid-lowering drugs and statins are enrolled in study.Eligible patients (n = 25) after signing an informed consent, are divide in metformin and Simvastatin groups. patients on Simvastatin group, will treated with 8 weeks 20 mg daily Simvastatin and 500 mg daily metformin and patients in control group( Metformin) use of 500mg daily metformin for 8 week. The primary outcome of this study is to determine the biochemical parameters at the end of the fourth week and eighth week. At the end of study the mean of biochemical parameters in the two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012110811408N1
Registration date:2013-01-30, 1391/11/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-01-30, 1391/11/11
Registrant information
Name
Somayeh Enayati
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8966
Email address
s.enayati@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of this project provided by the Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral simvastatin effect on reproductive outcomes and biochemical metabolic parameters in PCOS patients undergoing IVF
Public title
Evaluating the changes in outcome and serum metabolic biochemical parameters after oral Simvastatin administration in patients with poly cystic ovary syndrome undergoing IVF
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: All patients in reproductive age with pcos that refer to infertility clinic of fatemieh hospital of Hamadan, that agreed to participate in the study and complete the informed consent, and without history of endocrine disease, Recent use of lipid-lowering drugs and statins.
exclusion criteria: don't referring After getting treatment, arbitrary discontinuation of treatment
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan- mahdiyeh Street - Hamadan University of Medical Sciences - Department of Research and Technology - Office of the Ethics Committee of the University
City
hamadan
Postal code
Approval date
2012-08-16, 1391/05/26
Ethics committee reference number
16/35/9/1828/د/پ
Health conditions studied
1
Description of health condition studied
Poly Cystic Ovarian Syndrom
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome
Primary outcomes
1
Description
HDL
Timepoint
before of study and the fourth and eighth weeks
Method of measurement
with Biochemical laboratory techniques and in mg per deciliter
2
Description
LDL
Timepoint
before of study and the fourth and eighth weeks
Method of measurement
with Biochemical laboratory techniques and in mg per deciliter
3
Description
TG
Timepoint
before of study and the fourth and eighth weeks
Method of measurement
with Biochemical laboratory techniques and in mg per deciliter
4
Description
Testestroon
Timepoint
before of study and the fourth and eighth weeks
Method of measurement
with Biochemical laboratory techniques and in mg per deciliter
5
Description
GTT
Timepoint
before of study and the fourth and eighth weeks.
Method of measurement
with Biochemical laboratory techniques and in mg per deciliter
Secondary outcomes
empty
Intervention groups
1
Description
Tab Simvastatin group 20 mg daily and Tab Metformin 500 mg daily for 8 week
Category
Treatment - Drugs
2
Description
Tab Metformin 500 mg daily for 8 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
woman clinics of Hamadan Fatemieh hospital
Full name of responsible person
dr Somayeh Enayati
Street address
hamadan-kermanshah street-fatemiyeh hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences and Health ser
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid-fahmideh Street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences and Health ser
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
Hamadan University of Medical Sciences and Health services