Polycystic Ovarian Syndrome (PCO) is one of the most common causes of infertility due to anovulation. Clomiphene citrate (Clomid) and Metformin are categorized as ovulation induction drugs in these pationts. In the present study, the effect of Clomid and Metformin is compared in the treatment of infertility in PCO pationts. In a randomized controlled clinical trial, 104 infertile PCO patients with anovulation referred to infertility clinic of Bushehr University of Medical Sciences during 2010-2011 were studied in two equal groups. Informed written consent was obtained from all patients. For patients, Clomid was prescribed from the third day of menstruation for five days with 100mg per day or metformin was started with one tablet per day and was increased to two and three tablets. Ovulation was evaluated by ultrasonography at 13th-14th and measurment of serum progestron in 21th day and pregnancy was confirmed by ßHCG.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106236871N1
Registration date:2011-11-09, 1390/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-09, 1390/08/18
Registrant information
Name
Shahnaz Ahmadi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 4044
Email address
ahmadi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Bushehr University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-07-11, 1390/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clomiphen citrate versus metformin as first line approach for the treatment of anovulation in infertile patients with Polycystic Ovarian Syndrome
Public title
Selecting optimized method for ovulation induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile anovulating PCO women in reproductive age of 18-30 and BMI of 19-25. Exclusion criteria: Any abnormality in thyroid and prolactin tests; structural abnormalities of uterus and tubes; metabolic disorders; cardiac and liver disease; cushing disease and OCP users.
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Bushehr University of Medical Sciences
Street address
Paradise site of Bushehr University of Medical Sciences, Rishehr street, Bahmani
City
Bushehr
Postal code
Approval date
2011-04-28, 1390/02/08
Ethics committee reference number
20/18/3/4299/دپ
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
pregnancy
Timepoint
14 days after ovulation
Method of measurement
ßhCG Test
2
Description
Adequate follicle (16-22mm)
Timepoint
13th - 14th day of mensturation cycle
Method of measurement
Vaginal sonography
3
Description
Serum progestron level
Timepoint
The 21th day of mensturation cycle
Method of measurement
Biochemical methods for measuring progestron titer
4
Description
Alive fetus
Timepoint
The 7th week of pregnancy
Method of measurement
Vaginal sonography
Secondary outcomes
1
Description
Multiple pregnancy
Timepoint
7th week
Method of measurement
Ultasonography
Intervention groups
1
Description
First group: Metformin will be started at 500mg daily and increased to maximum dose of 1500 mg daily during 3 weeks.
Category
Treatment - Drugs
2
Description
Second group: clomiphene citrate 100 mg orally for 5 days since 3rd day of menstruation cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The outpatient clinic of Bushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Ahmadi
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
2
Recruitment center
Name of recruitment center
The outpatient clinic of Bushehr
Full name of responsible person
Dr. Shahnaz Ahmadi
Street address
Sangi street
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Maryam Ravanipoor
Street address
Bahmani
City
Booshehr
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, Bushehr 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
Bushehr University of Medical Sciences, Medical Faculty
Full name of responsible person
Dr shahnaz Ahmadi
Position
assistant professor of clinical obstetrics and gynecology
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
ahmadishahnaz2005@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences, Medical Faculty
Full name of responsible person
Dr Shahnaz Ahmadi
Position
assistant professor of clinical obstetrics and gynecology
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
ahmadishahnaz2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Faculty, Bushehr University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
Medical Student
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
Email
fmoradi66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)