Protocol summary

Summary
Aim: assessment effect of myoinositol on insulin resistance in women with poly cystic ovarian syndrome. Drawings: the diagnosis of PCOS was based on the Rotterdam criteria, which necessitated 2 of the following 3 features: 1. oligoovulation and anovulation (less than 6 times in 12 months) 2. Clinical or biochemical signs of hyperandrogenism such as acnea, allopecia or high androgen level 3. Polycystic ovaries on ultrasound examination. Design: The questionnaires were included height, weight, body mass index, waist, menstruation pattern, infertility, fasting glucose, fasting insulin, insulin resistance index, low density lipoprotein, high density lipoprotein, triglyceride, dehydroepiandastione, free testosterone were measured in these patients. Inclusion criteria: women who were between 20 and 40 years old, and had PCOS diagnosed by a gynecologist. Exclusion criteria: patients who were diagnosed with Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, hypothyroidism, hyperthyroidism, andogen secreting tumor, medications known to affect metabolic parameters, such as metformin and corticosteroid drugs, vitamin D, and serum calcium. Intervention: the patients received myoinositol 4 grams daily for 3 months and the pilot checked again three months after treatment. Written consent form was obtained from all patients. Primary outcome measure: fasting glucose, fasting insulin, HOMA IR. Secondary outcome measure: height, weight, body mass index, low density lipoprotein, high density lipoprotein, free testosterone, dehydoeoiandrastione, triglyceride.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010319426N4
Registration date: 2015-01-17, 1393/10/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-17, 1393/10/27
Registrant information
Name
Saghar Salehpour
Name of organization / entity
Shahid Behshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
saghar.salehpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Healthparsian.co and Vice chancellor for research, Shahid Beheshti University of Medical Science
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment the clinical effect of myoinositol on insulin resistence in women with PCOS
Public title
Assesment the clinical effect of myoinositol on insulin resistence in women with PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women who were between 20 and 40 years old, and had PCOS diagnosed by a gynecologist. Exclusion criteria: patients who were diagnosed with Cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia, hypothyroidism, hyperthyroidism, androgen secreting tumor; medications known to affect metabolic parameters, such as metformin and corticosteroids.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Vice chancellor for research, Shahid Beheshti University of Medical Science
Street address
SBMU_ School of medicine, 3td floor, Velenjak , Shahid Chamran highway, Tehran
City
Tehran
Postal code
193954719
Approval date
2014-11-20, 1393/08/29
Ethics committee reference number
SBMU.REC.1393.44

Health conditions studied

1

Description of health condition studied
Polycystic Ovarian Syndrome
ICD-10 code
E28.2
ICD-10 code description
Ovarian dysfunction, unspecified

Primary outcomes

1

Description
Fasting glucose
Timepoint
Before intervention and three months after treatment
Method of measurement
Blood serum

2

Description
Fasting insulin
Timepoint
Before intervention and three months after treatment
Method of measurement
Blood serum

3

Description
HOMA IR
Timepoint
Before intervention and three months after treatment
Method of measurement
Calculation by formola

Secondary outcomes

1

Description
Weight
Timepoint
Before intervention and three months after treatment
Method of measurement
Balance

2

Description
Height
Timepoint
Before intervention and three months after treatment
Method of measurement
Meter

3

Description
Body Mass Index
Timepoint
Before intervention and three months after treatment
Method of measurement
Formola

4

Description
Low density lipoprotein
Timepoint
Before intervention and three months after treatment
Method of measurement
Blood serum

5

Description
High density lipoprotein
Timepoint
Before intervention and two months after vitamin D injection
Method of measurement
Blood serum

6

Description
Free testosterone
Timepoint
Before intervention and two months after vitamin D injection
Method of measurement
Blood serum

7

Description
Dehydoepiandrasteione
Timepoint
Before intervention and two months after vitamin D injection
Method of measurement
Blood serum

8

Description
Triglyceride
Timepoint
Before intervention and two months after vitamin D injection
Method of measurement
Blood serum

Intervention groups

1

Description
Patients with dignosis of PCOD under treatment with myoinositol (powder) 4 gram daily for three months and primary and secondary outcome measure before and after reatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility & Reproductive Health Research Center Shahid Beheshti University of Medical Science
Full name of responsible person
Zahra Sadeghzadeh
Street address
Taleghani hospital , Velenjak, Shahid Chamran highway,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Science
Full name of responsible person
Mrs Zahra Khateri
Street address
SBMU_ School of medicine, 3td floor, Velenjak , Shahid Chamran highway, Tehran
City
Tehran
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, Shahid Beheshti University of Medical Science
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Healthparsian. com
Full name of responsible person
Melina Makhmour
Street address
Amirabad, tehran , Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Healthparsian. com
Proportion provided by this source
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
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Dr Saghar salehpour
Position
Associate professor
Other areas of specialty/work
Street address
Taleghani Hospital, IVF ward, Velenjak, Shahid Chamran higway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
saghar.salehpour2014@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Dr Sedighe Hosseini
Position
Gynecologist
Other areas of specialty/work
Street address
Taleghani Hospital, IVF ward, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
s_s_hoseini58@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Dr Saghar Salehpour
Position
Associate professor
Other areas of specialty/work
Street address
Taleghani Hospital, IVF ward,Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
saghar.salehpour2014@gmail.com
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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