Polycystic ovary syndrome (PCOS) is one of the most common causes of anovulatory infertility and affects 5-10% of women of reproductive age.The objective of this study is to test the effects of simvastatin on clomiphene response in cases of clomiphen citrate-resistant (CC- R) polycystic ovary syndrome (PCOS) patients .
Methods: In this quasi experimental study, we enrolled 25 anovulatory PCOS women who failed to ovulate by using only CC at Amir-Al-Momenin University General Hospital in Semnan, Iran. All patients received cyclic oral contraceptives (30µg of ethinyl estradiol and 150µg of desogestrol) from the 5th day of their spontaneous or progesterone(P) induced menstrual cycle plus simvastatine (20mg/day)) from the first day of cycle for 2 months. Then patients were given100 mg CC (Clomid, Iran Hormone) for 5 days starting from day 3 of their menstrual cycle. The primary outcome measures were ovulation, and pregnancy rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212043386N8
Registration date:2012-12-10, 1391/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-10, 1391/09/20
Registrant information
Name
Azam Azargoon
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 3401
Email address
a-azargoon@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2009-05-01, 1388/02/11
Expected recruitment end date
2011-12-20, 1390/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of simvastatin on clomiphen response in clomiphen – resistant women with polycystic ovary syndrome
Public title
Effects of simvastatin on clomiphen response in clomiphen – resistant women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: women who were 18-40 years of age, with a period of infertility more than 1.5 years and normal serum prolactin and thyroid function tests, they all had documented patent tubes by hysterosalpingography, had no other infertility factor, and failed to ovulate with a dose of CC of 150 mg /day for 5 days from day 3 of the period. The women who were diabetic, had hypertension or abnormal renal or liver function tests, and had undergone ovarian drilling were excluded from the study. Hirsutism was diagnosed when the Ferriman and Gallway score was >8(15).
The diagnosis of PCOS was according to the Rotterdam Criteria
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan Uiversity of Medical Sciences
Street address
Basij blvd
City
Semnan
Postal code
Approval date
2009-04-21, 1388/02/01
Ethics committee reference number
آ/2391
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
ovulation and pregnancy rates
Timepoint
after intervention
Method of measurement
BHCG and sonography
Secondary outcomes
1
Description
Change in BMI,
Timepoint
After intervention
Method of measurement
BMI=WT(kg)/H2(m)
2
Description
Endometrial thickness
Timepoint
On HCG day adminstration
Method of measurement
Sonography
3
Description
Size and numbers of follicles>18mm
Timepoint
On HCG day adminstration
Method of measurement
Sonography
Intervention groups
1
Description
We enrolled 25 anovulatory PCOS women who failed to ovulate by using only CC . All patients received cyclic oral contraceptives (30µg of ethinyl estradiol and 150µg of desogestrol) from the 5th day of their spontaneous or progesterone(P) induced menstrual cycle plus simvastatine (20mg/day)) from the first day of cycle for 2 months. Then patients were given100 mg CC (Clomid, Iran Hormone) for 5 days starting from day 3 of their menstrual cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center, Amiralmomenin Hospital
Full name of responsible person
Azam Azargoon
Street address
Madar square, Infertility center, Amiralmomenin Hospital
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Semnan- Basij Blvd
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Azam Azargoon
Position
Associated professor
Other areas of specialty/work
Street address
Madar square, Amiralmomenin Hospital
City
Semnan
Postal code
Phone
+98 23 1446 0077
Fax
+98 23 1446 1580
Email
a-azargoon@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Azam Azargoon
Position
Associated professor
Other areas of specialty/work
Street address
Madar square, Amiralmomenin hospital
City
Semnan
Postal code
3519734731
Phone
+98 23 1446 0077
Fax
+98 23 1446 1580
Email
a-azargoon@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Azam Azargoon
Position
Associated professor
Other areas of specialty/work
Street address
Madar square, Amiralmomenin hospital
City
Semnan
Postal code
3519734731
Phone
+98 23 1446 0077
Fax
+98 23 1446 1580
Email
a-azargoon2sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)