The aim of this study is to compare the efficacy of two drugs, Letrozole and Clomiphene Citrate( CC) combined with gonadotropins for ovarian stimulation in women candidate of IUI.160 patients enrolled in this study.
Inclusion criteria include of patients candidate of IUI( ovulatory factor; male factor infertility;patients with cervical factor; endometriosis and idiopathic infertility); normal ;pelvic USG and bilateral tubal patency and Exclusion Criteria include of patients with age more than 35; FSH more than 10 on day 3 of menstruation cycle; uterine and adnexal pathology; ovarian cyst on USG; impaired hepatic /renal function; Diabetes mellitus; history of hypersensitivity to the study drug or to its excipients; bilateral tubal obstruction on HSG.
Patients randomized to two groups: group A(n=80) (receive Letrozole - gonadotropin) and group B(n=80) (Clomiphene Citrate (CC)-gonadotropin). Group A received 5 mg Letrozole for 5 days from day 3 to 7 of menstrual cycle. In group B Clomiphene Citrate 100 mg was given for 5 days starting from day 3 of menstrual cycle. In addition, in both groups was administered 150 IU human menopausal gonadotropin (hMG)every day, starting on day 8 until human chorionic gonadotropin (hCG) administration. Ovulation was triggered with urinary HCG, when the leading follicle(s) reached 18 mm in diameter. A single IUI was performed 36-40 hours later. The Ovarian stimulation response (E2 levels and number of follicles, clinical pregnancy and endometrial thickness) was outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712141744N1
Registration date:2011-10-03, 1390/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-03, 1390/07/11
Registrant information
Name
Soheila Akbari
Name of organization / entity
Lorestan Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 66 1225 0368
Email address
akbari.s@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2008-12-20, 1387/09/30
Expected recruitment end date
2009-06-21, 1388/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of clomiphene citrate and letrozole in patients undergoing intra uterine semen injection on the pregnancy rate.
Public title
Clomiphene citrate vs letrozole in patients undergoing intra uterine semen injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate of IUI( ovulatory factor; male factor infertility; patients with cervical factor; endometriosis and idiopathic infertility); Normal Pelvic USG and bilateral tubal patency.
Exclusion Criteria: Age more than 35; FSH more than 10 on day 3 of menstruation cycle; Uterine and adnexal pathology e.g. leiomyoma; Ovarian cyst on USG., Impaired hepatic /renal function; Diabetes mellitus; History of hypersensitivity to the study drug or to its excipients; Bilateral tubal obstruction on HSG
Age
From 15 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Ethics committee of Lorestan University of Medical Sciences
Street address
Research and technology center, 3rd floor, Lorestan University of Medical Sciences, Pardis(Kamalvand)uUniversity complex, 3 km. road Khoramabad borojerd, Khoramabad
City
khoramabad
Postal code
381351698
Approval date
2009-03-08, 1387/12/18
Ethics committee reference number
9058/200
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 rate
Timepoint
14 days after intra uterine insemination
Method of measurement
Blood test for assay of BHCG
2
Description
Abortion rate
Timepoint
From positive test of BHCG to 20th weeks of gestation
Method of measurement
Pregnancy loss before 20th weeks of gestation determined with ultrasunogeraphy
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
In the time of HCG injection
Method of measurement
Transvaginal ultrasonogeraphy
2
Description
Number of follicles
Timepoint
In the time of HCG injection
Method of measurement
Transvaginal ultrasonograghy
3
Description
Serum estradiol level
Timepoint
In the time of hCG injection
Method of measurement
Blood test(microgram/dl)
Intervention groups
1
Description
Control group ( Clomiphene Citrate) :
Clomiphene Citrate 100 mg was given for 5 days starting from day 3 of menstrual cycle. In addition, human menopausal gonadotropin (hMG) 150 IU was administered every day, starting on day 8 until human chorionic gonadotropin (hCG) administration. Ovulation was triggered with urinary HCG, when the leading follicle(s) reached 18 mm in diameter. A single IUI was performed 36-40 hours later.
Category
Treatment - Drugs
2
Description
Intervention group ( Letrozole ) :
5 mg Letrozole for 5 days from day 3 to 7 of menstrual cycle.
In addition, human menopausal gonadotropin (hMG) 150 IU was administered every day, starting on day 8 until human chorionic gonadotropin (hCG) administration. Ovulation was triggered with urinary HCG, when the leading follicle(s) reached 18 mm in diameter. A single IUI was performed 36-40 hours later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lorestan university of medical sciences
Full name of responsible person
Soheila Akbari
Street address
Lorestan University of Medical Sciences, Pardis(Kamalvand) university complex, 3 km. road Khoramabad Borojerd, Khoramabad
City
Khoram abad
2
Recruitment center
Name of recruitment center
Kosar infertility center
Full name of responsible person
Maryam Ayazi Roozbahani
Street address
Kosar infertility center, Yegane Ed, Farmanie st., Tehran/Iran n
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Lorestan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hasan Kaeidi
Street address
Research and technology center, 3rd floor, Lorestan University of Medical Sciences, Pardis (Kamalvand) university complex, 3 km. road Khoramabad Borojerd, Khoramabad
City
Khoramabad
Grant name
124409
Grant code / Reference number
1193
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Lorestan 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
Erfan Hospital
Full name of responsible person
Ayazi Roozbahani Maryam
Position
Fellowship of infertility
Other areas of specialty/work
Street address
Erfan hospital, Infertility center, Riazi Bakhshayesh st.Tehran, Iran
City
Tehran
Postal code
------
Phone
+98 21 2235 9153
Fax
-------
Email
ayaziroz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan university of medical sciences
Full name of responsible person
Akbari Soheila
Position
Obstetric and Gynecologist
Other areas of specialty/work
Street address
Unit 5, 3rd floor, Yas bldg, Laleh St. Jandarmery Sq. Khoramabad, Iran