The aim of this study was to evaluate the efficacy of adding dexamethasone (dex) to clomiphene citrate (CC) in CC-resistant polycystic ovarian syndrome (PCOS) patients to improve ovulation. This study was performed on infertile PCOS patients that referred to Fateme-Zahra Infertility and Reproductive Health Research Center of Babol from 2007 to 2009. Sixty Patients divided in two groups and stimulation was done with dex+CC or placebo+CC. Main outcome measurements were rate of ovulation, pregnancy and matured follicles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807041760N2
Registration date:2010-05-21, 1389/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-03-21, 1388/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use of dexamethasone and clomiphene citrate in patients with polycystic ovarian syndrome resistant to clomiphene citrate
Public title
Use of dexamethasone and clomiphene citrate in patients with polycystic ovarian syndrome resistant to clomiphene citrate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having PCOS according to the Rotterdam criteria for diagnosis of PCOS, age between 18 and 35 years, period of infertility >1/5 years and normal DHEAS levels. Exclusion criteria: hyperprolactinaemia, hypercorticism or thyroidism, pelvic pathology or surgery, infertility factor other than anovulation.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical Sciences
Street address
Gangafroz Avenue
City
Babol
Postal code
4717641367
Approval date
2010-02-27, 1388/12/08
Ethics committee reference number
1008
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
ovulation
Timepoint
36-48 hr after HCG injection
Method of measurement
fluid in the cul-de-sac or corpus luteum formation, disappearance of pre-ovulatory follicle
2
Description
pregnancy
Timepoint
25 days after HCG administration
Method of measurement
transvaginal ultrasound examination
Secondary outcomes
1
Description
number of matured follicles
Timepoint
12-18 days after first of menstuaration
Method of measurement
sonography
Intervention groups
1
Description
Group I: Clomiphene Citrate, 100 mg, was given from 3rd day until 7th day plus dexamethasone 2mg/day orally in two divided doses
Category
Treatment - Drugs
2
Description
Group 2: Clomiphene Citrate, 100 mg, was given from 3rd day until 7th day plus folic acid tab from 3rd day until 12th day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & infertility hospital
Full name of responsible person
Seddigheh Esmaeilzadeh
Street address
Noshirvani steert
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Gangafroz 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 Chancellor for Research and Technology, 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
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center - Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 71112274881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Seddigheh Esmaeilzadeh
Position
Responsible of Fatemehzahra Fertility & Reproductive Health Research Center/Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Research center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
sesmael@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)