This is a randomized clinical trial which has two groups: In the intervention group there are 40 women with Polycystic Ovary Syndrome who will get Vitamin D two months before IUI.In control group there are 40 women,with Polycystic Ovary Syndrome who will get placebo two months before IUI.Our placebo is identical to vitamin D ampoules in all regards. It is hence made using sesame oil, the base compenent in vitamin D ampoules;it, however ,does not have any of the active ingredients of the very ampoule. Then patients will enter to COH-IUI and pregnancy rate in patients will be compared.
General information
Acronym
Role vitamin D in Reproductive success
IRCT registration information
IRCT registration number:IRCT201104216246N1
Registration date:2011-09-04, 1390/06/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-09-04, 1390/06/13
Registrant information
Name
Mojgan Asadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
asadim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology &Metabolism Research Center Tehran University Of Medical Sciences
Expected recruitment start date
2011-09-06, 1390/06/15
Expected recruitment end date
2012-01-05, 1390/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role Of Vitamin D In Reproductive Success Following Intra Uterin Insemination In Polycystic Ovary Syndrome Patients
Public title
Role Of Vitamin D In Reproductive Success Following Intra Uterin Insemination In Polycystic Ovary Syndrome Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All Patients with polycystic Ovary Syndrome who refered to infertility clinic ,candidate for IUI and Vitamin D Level Less than 100ng/ml .exclusion criteria: All Patients with other causes of infertility and patients with Vitamin D Level more than 100ng/ml.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Endocrinology& Metabolism Research Center
Street address
5th Floor,Shariati Hospital,North Kargar Ave,1411413137 Tehran Iran
City
Tehran
Postal code
Approval date
2011-02-10, 1389/11/21
Ethics committee reference number
E-00112
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
After14 days of sperm transfer
Method of measurement
B-hcG
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
At the time of fetal heart is seen
Method of measurement
vaginal sonography
Intervention groups
1
Description
Intervention group : muscular injection of Vitamin D 300000 unit
Category
Treatment - Drugs
2
Description
Control group: muscular injection of placebo (Our placebo is made using sesame oil, the base component in vitamin D ampoule)