Evaluating the change of antimullerian hormone three month after metformine therapy in polycystic ovarian syndrome in comparison with control group(women that use placebo instead of metformine)
The aim of the study is to introduce antimullerian hormone(AMH) as a factor for measuring response to metformine therapy in polycystic ovarian syndrome.
This study is triple blind placebo controlled trial.The sample will be chosen from the women suffer from polycystic ovarian syndrome that refer to the clinic. patients select their kind of treatment with selecting two different way of treatment including metformine and placebo (simple randomized method). Inclusion criteria:1-Age between 18-45 2- Patienst must not suffer from cardiovascular. renal and hepatic disease 3- Patients must be new cases
Exclusion criteria: 1- use of oral anticoagulant drug during study 2-stop using metformine during study 3-pregnancy 4-body mass index below eighteen 5- sever hirsutism 6-amenorrhea 7-use of clomiphene citrate or other ovulation induction drugs.
The volume of sample is 42 (21 in intervention group 21 in control group). Metformine therapy will be done three times a day for three months in intervention group and in control group with placebo. AMH level and clinical situation of patient will be assessed at the beginning and after three months to identify clinical response to metformine and compare it with AMH level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081918858N1
Registration date:2015-02-21, 1393/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-21, 1393/12/02
Registrant information
Name
Masoud Rahmanian
Name of organization / entity
Diabet Research Center, Yazd Shahid Sadughi University Of Mdical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1728 0215
Email address
rahmanian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University Of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the change of antimullerian hormone three month after metformine therapy in polycystic ovarian syndrome in comparison with control group(women that use placebo instead of metformine)
Public title
Evaluating the effect of metformine on antimullerian hormone(AMH ) in polycystic ovarian syndrome –a clinical trial
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:1-age between 18-45 2- patienst without cardiovascular. renal and hepatic disease 3- patients must be new cases
exclusion criteria: 1- use of oral anticoagulant drug during study 2-stop using metformine during study 3-pregnancy 4-body mass index below eighteen 5- sever hirsutism 6-amenorrhea7-use of clomiphene citrate or other ovulation induction drugs 8-cushing syndrome 9- using drugs that cause hirsutism 10- congenital adrenal hyperplasia 11- hypothyroidism 12- androgen producing ovarian tumors 13- prolactinoma 14- diabet
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Diabetic Research Center, Yazd Shahid Sadoughi Univercity Of Medical Science
Street address
Yazd Diabet Research Center، Talar Honar Alley، Bahonar to Azadi Square، Shahid Sadoughi Blvd، Yazd
City
Yazd
Postal code
Approval date
2014-08-17, 1393/05/26
Ethics committee reference number
102128
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Testesterone
Timepoint
before treatment and after three months
Method of measurement
Ng/Ml
2
Description
Hip to waist ratio
Timepoint
Before treatment and after three months
Method of measurement
Without any unit
3
Description
FSH
Timepoint
before treatment and after three months
Method of measurement
IU/L
4
Description
LH
Timepoint
before treatment and after three months
Method of measurement
IU/L
5
Description
Age
Timepoint
Before treatment
Method of measurement
Year
6
Description
Hirsutism score
Timepoint
Before treatment and after three months
Method of measurement
Freeman galway score
7
Description
prolactin
Timepoint
before treatment and after three months
Method of measurement
Ng/Ml
8
Description
AMH
Timepoint
before treatment and after three months
Method of measurement
Mg
9
Description
BMI
Timepoint
before treatment and after treatment
Method of measurement
m²/kg
10
Description
kind of treatment
Timepoint
Before treatment
Method of measurement
mg
11
Description
17(oh)progesterone
Timepoint
before treatment
Method of measurement
Ng
12
Description
Menstural disorder
Timepoint
Before treatment and after three months
Method of measurement
Cycles lessthan26 days and more than 30 days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Metformin, 500mg oral tablet, Three times a day for three months
Category
Treatment - Drugs
2
Description
Control group: Placebo,oral tablet, Three times a day for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Clinic
Full name of responsible person
Street address
City
yazd
2
Recruitment center
Name of recruitment center
Khatamolanbia Clinic
Full name of responsible person
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Diabet Research Center, Yazd Shahid Sadoughi Univercity Of Medical Science
Full name of responsible person
Masoud Rahmanian
Street address
Yazd Diabet Research Center, Talar Honar Alley, Bahonar to Azadi Square, Shahid Sadoughi Blvd, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Diabet Research Center, Yazd Shahid Sadoughi Univercity Of Medical Science
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Diabet Research Center، Shahid Sadoughi University of Medical Science
Full name of responsible person
Masoud Rahmanian
Position
Endocrinologist
Other areas of specialty/work
Street address
Yazd Diabet Research Center, Talar Honar Alley, Bahonar to Azadi Square, Shahid Sadoughi Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3728 0228
Fax
+98 35 3728 0216
Email
rahmanian@ssu.ac.ir drmasoudrahmanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Diabet Research Center, Shahid Sadoughi Univercity of Medical Science
Full name of responsible person
Masoud Rahmanian
Position
Endocrinologist
Other areas of specialty/work
Street address
Yazd Diabet Research Center, Talar Honar Alley, Bahonar to Azadi Square, Shahid Sadoughi Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3728 0228
Fax
+98 35 3728 0216
Email
Rahmanian@ssu.ac.ir Drmasoudrahmanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)