Anovulation is one of the most common causes of infertility. Different drugs in various ways are prescribed for its treatment. Clomiphene citrate (Clomid) and Letrozole are categorized as ovulation induction drugs. In the present study, the effect of Clomid and Letrozole, using step up method, is compared in the treatment of infertility. In a randomized controlled clinical trial, 200 infertile patients with anovulation referred to infertility clinic of Bushehr University of Medical Sciences during 2008-2010 were studied in two equal groups. Informed written consent was obtained from all patients. For patients in each group, Letrozole or Clomid was prescribed from the third day of menstruation for five days in an increasing protocol of one, two and three tablets. Ovulation and endometrial thickness were evaluated by ultrasonography in 13th-14th day and pregnancy was confirmed by ßHCG.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904154339N1
Registration date:2011-02-07, 1389/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-07, 1389/11/18
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research management center of Bushehr University of Medical Sciences
Expected recruitment start date
2009-03-10, 1387/12/20
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
Clomiphene citrate and Letrozole comparison in the treatment of anovulating patients
Public title
Selecting optimized method for ovulation induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile anovulating women in reproductive age
Exclusion criteria: Any abnormality in thyroid and prolactin tests and structural abnrmalities of uterus and tubes.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Research managment center of Bushehr University of Medical Sciences
Street address
Paradise site of Bushehr University of Medical Sciences, Rishehr street, Bahmani, Bushehr
City
Bushehr
Postal code
Approval date
2009-03-09, 1387/12/19
Ethics committee reference number
20/18/3/2407/دپ
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adequate follicle
Timepoint
The 13th - 14th day of menstruation cycle
Method of measurement
Vaginal sonography
2
Description
Endometrial thickness
Timepoint
The 13th - 14th day of menstruation cycle
Method of measurement
Vaginal sonography
3
Description
Estradiol concentration
Timepoint
The 13th - 14th day of menstruation cycle
Method of measurement
Biochemical methods for mesuring estradiol titer
4
Description
Pregnancy
Timepoint
14 days after ovulation
Method of measurement
ßhCG Test
5
Description
Alive fetus
Timepoint
The 7th week of pregnancy
Method of measurement
Vaginal sonography
Secondary outcomes
1
Description
Ovarian cyst
Timepoint
The 13th - 14th day of menstruation cycle
Method of measurement
Vaginal sonography
2
Description
Abnormal Uterine Bleeding
Timepoint
During menstruation cycle
Method of measurement
Patients history
Intervention groups
1
Description
Letrozole 2.5 or 5 or 7.5 mg orally according to setup protocol for 5 days since 3rd day of menstruation cycle in first group
Category
Treatment - Drugs
2
Description
clomiphene citrate 50 or 100 or 150 mg orally according to setup protocol for 5 days since 3rd day of menstruation cycle in second group
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. Elham Rahmani
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research managment center of Bushehr University of Medical Sciences
Full name of responsible person
Dr. Maryam Ravani pour
Street address
Paradise site of Bushehr University of medical sciences, Rishehr street, Bahmani, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research managment center of 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, Bushehr
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. Elham Rahmani
Position
assistant professor of clinical obstetrics and gynecology
Other areas of specialty/work
Street address
Medical Faculty, Bushehr University of Medical Sciences, Moallem street, Bushehr
City
Bushehr
Postal code
Phone
+98 77 1252 4044
Fax
+98 77 1252 4044
Email
rahmani@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)