Adding Metformin to Clomiphen to improve ovulation rate in Clomiphen resistant women with polycystic ovarian syndrome: A randomized clinical trial study
The aim of this study is to compare the effectiveness of adding Metformin to Clomiphen Citrate in women with polycystic ovarian syndrome (PCOS) to improve ovulation. This multicenter single-blind randomized controlled trial study was performed on 334 PCOS patients in Babol, Iran. Patients were divided in two groups randomly and ovulation induction was done with Clomiphen Citrate (CC) 50mg 2/day in both groups and the combination of CC and Metformin 500mg 3/day in intervention group. Number of mature follicle and pregnancy rate and number of patients who had dominant follicle were evaluated in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904174306N1
Registration date:2010-08-24, 1389/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-24, 1389/06/02
Registrant information
Name
Masoumeh Golsorkhtabar Amiri
Name of organization / entity
Fatemeh-Zahra infertility and Reproductive Health Research center, Babol University of Medical Scien
Country
Iran (Islamic Republic of)
Phone
+98 11 1227 4881
Email address
s.esmaeelzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology of Babol University of Medical Sciences
Expected recruitment start date
2007-01-01, 1385/10/11
Expected recruitment end date
2009-01-01, 1387/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adding Metformin to Clomiphen to improve ovulation rate in Clomiphen resistant women with polycystic ovarian syndrome: A randomized clinical trial study
Public title
Does ovulation rate improve in Clomiphen resistant women with polycystic ovarian syndrome by adding Metformin to Clomiphen?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Infertile patients with PCOS. 2. Normal values of TSH and prolactin 3. Normal creatinin level 4. Normal liver function (SGOT, SGPT). Exclusion criteria: 1. hyperprolactinemia 2. thyroid disease 3.endometriosis 4. tubal factor 5. male factor 6. metformin with side effect background 7. diabetes mellitus.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
334
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chanceller for Research and Technology of Babol University of medical sciences
Street address
Gangafrooz St.
City
Babol
Postal code
47135-547
Approval date
2008-02-27, 1386/12/08
Ethics committee reference number
30/1/9056
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrom
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Number of mature follicle
Timepoint
12th-16th day of cycle
Method of measurement
transvaginal ultrasound
Secondary outcomes
1
Description
Pregnancy
Timepoint
16 days after IUI (16-18 cycle day)
Method of measurement
BHCG Examination
Intervention groups
1
Description
Clomiphen 50 mg, 2 per day, 5-7 days
Category
Treatment - Drugs
2
Description
Tab Metformin 500 mg, 3 per day, 3 month + Clomiphen 50 mg, 2 per day, 5-7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh-Zahra Infertility and Reproductive Health Research Center
Full name of responsible person
Dr. Zahra Basirat
Street address
Torkmahalleh - after Mohamad Hassan khan bridge
City
Babol
2
Recruitment center
Name of recruitment center
Mehrgan hospital, Infertility center
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceller of Research and Technology of Babol University of medical sciences
Full name of responsible person
Dr. Amrollah Mostafazadeh
Street address
Gang afrooz avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller of Research and Technology of Babol 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
Fatemeh-Zahra Infertility and Reproductive Health Research Center,Babol University of Medical Scienc
Full name of responsible person
Masoumeh Golsorkhtabar Amiri
Position
BS.c
Other areas of specialty/work
Street address
Torkmahalle - after Mahamad Hassan Khan bridge
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
s.esmaeelzadeh@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh-Zahra Infertility and Reproductive Health Research Center, Babol University of Medical Scien
Full name of responsible person
Zahra Basirat
Position
M.D.
Other areas of specialty/work
Street address
Torkmahalleh - after Mohamad Hassan khan bridge
City
Babol
Postal code
Phone
+98 11 1227 4882
Fax
Email
s.esmaeelzadeh@ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh-Zahra Infertility and Reproductive Health Research Center, Babol University of Medical Scien
Full name of responsible person
Masoumeh Golsorkhtabar Amiri
Position
B.Sc
Other areas of specialty/work
Street address
Torkmahalleh - after Mohamad Hassan khan bridge
City
Babol
Postal code
47135-547
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
m.golsorkhtabar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)