Objectives: To compare pregnancy rate between the chromium picolinate group and metformin group in clomiphen citrate resistant PCOS patients.
Methods: This was a randomized clinical trial being performed at university affiliated clinices including 92 women with clomiphen citrate-resistant PCOS who were randomly assigned to receive chromium picolinate (200µg daily) or metformin (1500mg daily) for 3 months.Pregnancy rate after 3 months was our major outcome. Anthropometric and hormonal profile were measured and compared before and after treatment.
Inclusion criteria: poly cystic ovaries;clomiphene resistant
;infertile.
Exclusion criteria:any medical disease.
General information
Acronym
non
IRCT registration information
IRCT registration number:IRCT201203139281N1
Registration date:2012-06-14, 1391/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-14, 1391/03/25
Registrant information
Name
Sedigheh Amooee
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 2426
Email address
amooee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Metformin and Chromium picolinate on pregnancy rate in Clomiphene Citrate-Resistant Polycystic Ovary Patients
Public title
Comparison of two drug for poly cystic ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: poly cystic ovaries;clomiphene resistant
;infertile.
Exclusion .criteria:any medical disease like diabetes;Cushing’s syndrome; hyperprolactinemia ; thyroid disease ; other endocrinopathies ; oral contraceptives (OCPs); any medications that interfere with lipid metabolism.
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
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
shiraz university of medical science ,ethics committee
Street address
Zand street
City
Shiraz
Postal code
713451975
Approval date
2012-03-05, 1390/12/15
Ethics committee reference number
5390
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
pregnancy rate
Timepoint
3 months after starting
Method of measurement
pregnancy test
Secondary outcomes
1
Description
pateint telorance testestron
Timepoint
each month
Method of measurement
lab data questioare
Intervention groups
1
Description
In first group patients take1500mg/day metformine in 3 divided dosage
Category
Treatment - Drugs
2
Description
In second group patients take chromium picolinate200mcg /day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
infertility center
Full name of responsible person
Street address
zand avenue
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
vice chanceller ,Dr.Gholam reza Hatam
Street address
Zand avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sedigheh Amooee
Position
Assistant professor
Other areas of specialty/work
Street address
Gyn ward, Shahid Faghihi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
sedighehamooee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedigheh Amooee
Position
Assistant professor
Other areas of specialty/work
Street address
Gyn ward, Shahid Faghihi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
sedighehamooee@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedigheh Amooee
Position
Assistant professor
Other areas of specialty/work
Street address
Gyn ward, Shahid faghihi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)