Type of study: prospective randomized clinical trial. Population studied: infertile women between 20 and 35 years old without underlying disease. Sample size: 65. The patients are divided into two groups. The intervention group is given clomiphene citrate tablet and control group is given Letrozole tablet. Both groups were administered gonadotropin. Then in the ultrasound series when the number of follicles 22-18 milimeter to 5-2 number were administered one ampoule hCG (the amount of ten thousand units). In this day, was measured the number of follicles larger than 14mm and Endometrial thickness in trans vaginal sonography. In follow up, the two groups are compared clinical and chemical pregnancy rates and complications of gonadotropins.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106256871N2
Registration date:2012-08-08, 1391/05/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-08, 1391/05/18
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
Management Research of Bushehr University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-05-05, 1390/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Clomiphene Citrate and Letrozole in pregnancy rate after intrauterine insemination
Public title
The effect of inducer drugs knowing ovulation fertility after IUI procedure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: duration of infertility for more than a year, less than 35 years of age, ensuring the openness of the fallopian tubes at laparoscopy or hysterosonography and attended at least 10 million sperm per milliliter of semen. Exclusion criteria: age greater than 35 years, moderate and severe endometriosis, basal serum FSH> 10mIU/ml, Hyprprvlaktynvma, hyperthyroidism, Cushing's syndrome, heart and liver disorders, and nonclassic Congenital adrenal hyperplasia, drugs and other drugs Zddyabt hormonal, organic pelvic diseases, previous pelvic Vjrahy
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:
65
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
Bushehr University of Medical Sciences
Street address
Bushehr.Pardis's Site of Bushehr University of Medical Sciences , Research Management
City
Bushehr
Postal code
Approval date
2010-12-02, 1389/09/11
Ethics committee reference number
B-9013-2
Health conditions studied
1
Description of health condition studied
Female infertility associated with male factors
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors
Primary outcomes
1
Description
The number of follicles larger than 14milimeter
Timepoint
day of human chrionic gonadotropin administration
Method of measurement
Trans Vaginal Sonography
2
Description
Endometrial thickness
Timepoint
Day of administration hCG
Method of measurement
Trans Vaginal Sonography
Secondary outcomes
1
Description
multiple pregnancy
Timepoint
14 days after confirmation of chemical pregnancy
Method of measurement
Trans Vaginal Sonography
2
Description
Ovarian Hyper Stimulation Syndrom
Timepoint
after confirmation pregnancy
Method of measurement
History and Phisical exam and symptoms
3
Description
Chemical pregnancy
Timepoint
16 day after administration of human chorionic gonadotropin
Method of measurement
β-hCG
4
Description
Clinical Pregnancy
Timepoint
14 day after confirmation of chemical pregnancy
Method of measurement
Trans Vaginal Sonography
Intervention groups
1
Description
Letrozole group(group A) is administrated tablet Letrozole 10miligram,daily,orally,from 3th-7th day of menstural cycle and two gonadotropin in 8th day and one gonadotropin in 9th day of menstural cycle.and when follicles 18-22mm to 2-5,one hCG ampoule (10000 units)was administrated.
Category
Treatment - Drugs
2
Description
Clomiphene Citrate group(group B) is administrated tab CC 100 mg,daily,orally,from 3th-7th day of menstural cycle and two gonadotropins in 8th day and one gonadotropin in 9th day of menstural cycle.Amp hCG was administrated simillar to group A.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abolfazl women`s Clinic
Full name of responsible person
Dr. Shahnaz Ahmadi
Street address
Clinic Abolfazl- field hospital -Bushehr
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Management Research of Bushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Ahmadi
Street address
Management Research, Pardis's site of Bushehr University of Medical Sciences, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Management Research of Bushehr University of Medical Sciences