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The effects of metformin on anthropometric, metabolic and hormonal changes in polycystic ovarian syndrome

Protocol summary

Summary
The polycystic ovary syndrome (PCOS) is an extremely common disorder. Although PCOS is known to be associated with reproductive morbidity and increased risk for endometrial cancer, diagnosis is especially important because PCOS is now thought to increase diabetes and cardiovascular risk. Objective: The main objective of the present study was to determine the effects of metformin on anthropometric, metabolic and hormonal changes in PCOS. Design: This is a non randomized before and after clinical trail. Setting and conduct: Infertile reproductive age women referred to Infertility clinic Fatemie, Hospital, Hamedan, Iran between May 2008 and August 2009. Participants: 28 women with PCOS according to the Rotterdam criteria. Intervention: Metformin 500mg orally TDS for 12 weeks. Main outcome: The anthropometric characteristics of the patients and mean ovarian volume and plasma level of FBS , lipid profile, LH, FSH, Estradiol, Testosterone, 17OHP, DHEAS, CRP, Homocysteine before and after treatment .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903244176N1
Registration date: 2008-07-26, 1387/05/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2008-07-26, 1387/05/05
Registrant information
Name
Nosrat Neghab
Name of organization / entity
Hamedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
nosratneghab@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan university of medical science/Pro vice chancellor for research
Expected recruitment start date
2008-07-26, 1387/05/05
Expected recruitment end date
2009-10-27, 1388/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of metformin on anthropometric, metabolic and hormonal changes in polycystic ovarian syndrome
Public title
The effects of metformin on anthropometric, metabolic and hormonal changes in polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Reproductive age women referred due to infertility. Polycystic ovarian syndrome was defined as the presence of more than 12 cysts, 2–9 mm in diameter in one plane in at least one ovary and increased stroma, usually combined with increased ovarian volume >10 ml in sonography and clinical or biochemical hyperandrogenism. Subjects should have normal prolactin, thyroid, renal and hematological indices. No participant had received metformin or other hormonal treatment within the 3 months prior to study. Exclusion criteria included concurrent hormone therapy within the previous 6 weeks, any chronic disease that could interfere with the absorption, distribution, metabolism or excretion of metformin, renal or liver disease, being an smoker, doing intense physical activity, having lost 3 kg of body weight in the 2 months preceding the study
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: 28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan university of medical science/Ethics committee
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street, Research committee
City
Hamedan
Postal code
Approval date
2008-07-23, 1387/05/02
Ethics committee reference number
16/35/9/56566

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
Waist to hip cicumference
Timepoint
12 weeks
Method of measurement
physical exam

2

Description
BMI
Timepoint
12 weeks
Method of measurement
kilogramm/M2 physical exam

3

Description
Menstrural cycles
Timepoint
12 weeks
Method of measurement
History taking

4

Description
Ovarian volume
Timepoint
12 weeks
Method of measurement
Trans vaginal sonography

5

Description
Testosterone
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

6

Description
LDL
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

7

Description
HDL
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

8

Description
TG
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

9

Description
Cholestrol
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

10

Description
Homocysteine
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

11

Description
CRP
Timepoint
12 weeks
Method of measurement
Lab test, Blood sampling

Secondary outcomes

1

Description
Weight
Timepoint
12weeks
Method of measurement
Physical exam

2

Description
Blood pressure
Timepoint
12weeks
Method of measurement
Physical exam

3

Description
Acne
Timepoint
12weeks
Method of measurement
Physical exam

4

Description
Hirsutism
Timepoint
12weeks
Method of measurement
Physical exam

5

Description
LH
Timepoint
12weeks
Method of measurement
Lab test, Blood sampling

6

Description
FSH
Timepoint
12weeks
Method of measurement
Lab test, Blood sampling

7

Description
Estradiol
Timepoint
12weeks
Method of measurement
Lab test, Blood sampling

8

Description
17OH Progesterone
Timepoint
12weeks
Method of measurement
Lab test, Blood sampling

9

Description
DHEAS
Timepoint
12weeks
Method of measurement
Lab test, Blood sampling

Intervention groups

1

Description
All patients received 1500 mg metformin per day (500 mg three times a day) for 12 weeks orally
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility clinic, Fatemie Hospital, Hamedan, Iran
Full name of responsible person
Dr Marzie Farimani Sanoee
Street address
Infertility clinic, Fatemie Hospital
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan university of medical sciences/Pro vice chancellor for research
Full name of responsible person
Dr Abas Zamanian
Street address
Research committee, School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan university of medical sciences/Pro vice chancellor for research
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Marzie Farimani Sanoee
Position
Associated professor
Other areas of specialty/work
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
dr_farimani@yahoo.com; drneghab@yahoo.com
Web page address
www.umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Marzie Farimani Sanoee
Position
Associated professor
Other areas of specialty/work
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
dr_farimani@yahoo.com; drneghab@yahoo.com
Web page address
www.umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan university of medical sciences
Full name of responsible person
Dr Marzie Farimani Sanoee
Position
Associated professor
Other areas of specialty/work
Street address
School of Medicine, Hamedan University of Medical Sciences, Shahid Fahmideh Street
City
Hamdan
Postal code
Phone
+98 81 1827 6295
Fax
Email
dr_farimani@yahoo.com; drneghab@yahoo.com
Web page address
www.umsh.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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