This was a randomized controlled trail in which 44 infertile women with Poly Cystic Ovary Syndrome participated. Patients were divided in two groups, 22 members in each group. Intervention group received daily dose of 50mlg clomiphene tablet with 400 units of vitamin D3 and 1000 mg calcium; control group received daily dose of 50 mg clomiphene tablet with placebo. In order to measure follicles size, patients underwent sonography during three menstruation cycles, each time at the 13th day of menstruation.
General information
Acronym
Effect of Calcium-vitamin D in induction-ovulation
IRCT registration information
IRCT registration number:IRCT201105096426N1
Registration date:2011-06-21, 1390/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-21, 1390/03/31
Registrant information
Name
Robabeh Mohammadbeigi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1323 9794
Email address
robabe.mohammadbeigi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Calcium-vitamin D in efficacy of induction-ovulation in infertile women with polycystic ovary syndrome
Public title
Effect of Calcium-vitamin D in efficacy of induction-ovulation in infertile women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primary or secondary infertility due PCOS
Exclusion criteria: Proved Endocrine diseases
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Ave.
City
Sanandaj
Postal code
Approval date
2010-02-17, 1388/11/28
Ethics committee reference number
p14p1203
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Follicles' size
Timepoint
Sixty days after the beginning of the study
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: daily dose of 50mlg clomiphene tablet with 400 units of vitamin D3 and 1000 mg calcium
Category
Treatment - Drugs
2
Description
Control group: daily dose of 50 mg clomiphene tablet with a placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Robabeh Mohammadbeigi
Street address
Keshavarz Ave
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Ataollah Heidari
Street address
Kurdistan University of medical sciences, Pasdaran Ave
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Robabeh Mohammadbeigi
Position
Assistant Prof.
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz Ave,
City
Sanandaj
Postal code
Phone
+98 912 310 6438
Fax
Email
robabe.mohammadbeigi@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Robabeh Mohammadbeigi
Position
Assistant Prof.
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
Phone
+98 912 310 6438
Fax
Email
robabe.mohammadbeigi@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
Robabeh Mohammadbeigi
Position
Associated Prof
Other areas of specialty/work
Street address
Keshavarz Ave
City
Sanandaj
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)