Protocol summary

Summary
The aim of this randomized single blind clinical trial study is to investigate the effect of acarbose and metformin use on ovulation induction success in women with polycystic ovary syndrome. Inclusion criteria: age 20-40 years, women with polycystic ovary syndrome diagnosed by the rotterdam consensus criteria. Exclusion criteria: Smoking, Cushing's syndrome, thyroid function disorders, androgen secreting tumors, patients with liver disease, kidney disease, heart disease, diabetes, and use of other drugs for polycystic ovary syndrome. A total of 60 women with polycystic ovarian syndrome were selected and randomly divided in two control and intervention groups using block method of 4. Intervention group receive acarbose 100 mg/day for 3 months. This method that in the first week they receive 1 tablet, second week two tablets and third week three tablets per day. Control group receive metformin 500 mg/day for 3 months. This method that in the first week they receive 1 tablet, second week two tablets and third week three tablets per day. All patients underwent laboratory examination before intervention including metabolic parameters (fasting sugar, fasting insulin, triglycerides and cholesterol) and clinical performance (hirsutism and hypertension). At the end of 3 months for the above they shall be examined and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092912789N7
Registration date: 2014-11-05, 1393/08/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-05, 1393/08/14
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effects of acarbose and metformin use on ovulation induction success in women with polycystic ovary syndrome
Public title
Comparison of the effects of acarbose and metformin on ovulation induction success
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20-40 years, women with polycystic ovary syndrome diagnosed by the rotterdam consensus criteria. Exclusion criteria: Smoking, Cushing's syndrome, thyroid function disorders, androgen secreting tumors, patients with liver disease, kidney disease, heart disease, diabetes, and use of other drugs for polycystic ovary syndrome.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Researcher is not aware of patient grouping. Patients were followed by resident of gynecology during the study period.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
14/26288

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Hirsutism
Timepoint
Before intervention -Three months after intervention
Method of measurement
Using Feriedman and Galway Scale

2

Description
Fasting insulin serum level
Timepoint
Before intervention -Three months after intervention
Method of measurement
Elisa assays

3

Description
Fasting sugar serum level
Timepoint
Before intervention -Three months after intervention
Method of measurement
Enzyme

4

Description
Blood pressure
Timepoint
Before intervention -Three months after intervention
Method of measurement
Barometers

Secondary outcomes

1

Description
Triglyceride serum level
Timepoint
Before intervention -Three months after intervention
Method of measurement
Serological test with Electro Komolynsans method

2

Description
Cholestrol serum level
Timepoint
Before intervention -Three months after intervention
Method of measurement
Serological test with Electro Komolynsans method

3

Description
LDL serum level
Timepoint
Before intervention -Three months after intervention
Method of measurement
Serological test with Electro Komolynsans method

4

Description
HDL serum level
Timepoint
Before intervention -Three months after intervention
Method of measurement
Serological test with Electro Komolynsans method

Intervention groups

1

Description
Intervention group receive acarbose 100 mg/day for 3 months. This method that in the first week they receive 1 tablet, second week two tablets and third week three tablets per day.
Category
Treatment - Drugs

2

Description
Control group receive metformin 500 mg/day for 3 months. This method that in the first week they receive 1 tablet, second week two tablets and third week three tablets per day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Somaye Mohammadpour
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
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, Kurdistan University of Medical Sciences
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
Kurdistan University of Medical Sciences
Full name of responsible person
Somaye Mohammadpour
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
mohamadjamshidi87@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Masomeh Rezaei
Position
Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
masomeh.rezaei@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Somaye Mohammadpour
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sananadaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
Web page address

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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