Comparing the treatment outcomes between letrozole and Clomiphene citrate (CC) combined with Gonadotropins in CC resistant Polycystic Ovarian Syndrome (PCOS) patients
The aim of this study is to compare the treatment outcome between letrozole and Clomiphene citrate (CC) combined with Gonadotropins in CC resistant Polycystic Ovarian Syndrome (PCOS) patients. A total of 130 patients with PCOS referring to Al-Zahra infertility clinic will be recruited after signing written informed consents. The patients in the first group will receive Clomiphene Citrate, 100mg/day and in the second group letrozole 5mg/day is started from the third day of menstrual cycle to seventh day and gonal F will be used from 7th day at a fix dosage of 75 IU in both groups. Transvaginal ultrasonography will be performed on tenth day in order to measure endometrial thickness and follicular size and the dosage adjusted in the case of inappropriate follicle size, 10000IU HCG is given intramuscularly when at least one follicle reaches to a size of 18-20 mm and IUI will be applied after 36-40 hours later. E2 will also be measured on the day of HCG injection. The patients with more than three dominant follicles or inadequate response or absence of at least one dominant follicle on twelfth day of the cycle will be excluded. Rate of ovulation, pregnancy rate and treatment failure will be compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106271233N2
Registration date:2011-07-30, 1390/05/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-30, 1390/05/08
Registrant information
Name
Maryam Asgharnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
asgharnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research Guilan University of Medical Sciences
Expected recruitment start date
2011-09-12, 1390/06/21
Expected recruitment end date
2013-09-12, 1392/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the treatment outcomes between letrozole and Clomiphene citrate (CC) combined with Gonadotropins in CC resistant Polycystic Ovarian Syndrome (PCOS) patients
Public title
Comparison of treatment outcomes between letrozole with Gonadotropins in Polycystic Ovarian Syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having PCOS according to Rotterdam criteria and, infertility for one year, age 20-39 years old
Exclusion criteria: tubal obstruction, infertility with male factor, hypersensitivity to Clomiphene Citrate or letrozole, presence of diabetes, thyroid or kidney disease, ovarian drilling, ovarian cyst on day 3 of menstrual cycle
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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, Guilan University of Medical Sciences
Street address
Mellat St., Namjoo Ave.
City
Rasht
Postal code
Approval date
2010-12-11, 1389/09/20
Ethics committee reference number
11937
Health conditions studied
1
Description of health condition studied
Disorders of other endocrine glands
ICD-10 code
E28
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Every 2-3 days
Method of measurement
Transvaginal ultrasonography
Secondary outcomes
1
Description
Follicles greater than 16mm
Timepoint
Every 2-3 days
Method of measurement
Transvaginal sonography
2
Description
Clinical pregnancy
Timepoint
14days after IUI
Method of measurement
Ultrasonography two weeks after positive BHCG for finding gestetaional sac
3
Description
Chemical pregnancy
Timepoint
14days after IUI
Method of measurement
bHCG measurment
4
Description
E2 level
Timepoint
Once in a cycle
Method of measurement
On the day of HCG injection by blood sampling
5
Description
Cancellation rate
Timepoint
Every 2-3 days
Method of measurement
Transvaginal sonograhy
6
Description
The number of Gonadotropines used
Timepoint
at the end of the cycle
Method of measurement
Number of Ampoules
Intervention groups
1
Description
Clomiphene citrate is started from day 3 to 7 then Gonal F 75IU/day is used from 7th day of menstrual cycle
Category
Treatment - Drugs
2
Description
Letrozol is started from day 3 to 7 then Gonal F 75IU/day is used from 7th day of menstrual cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research-Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave. Vice Chancellor for research
City
Rasht
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-Guilan 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
Giulan University of Medical Sciences
Full name of responsible person
Dr. Maryam Asgharnia
Position
Associate Professor- Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
maryamasgharnia@yahoo.comh_fertility@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Giulan University of Medical Sciences
Full name of responsible person
Dr. Maryam Asgharnia
Position
Associate Professor- Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
maryamasgharnia@yahoo.comh_fertility@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S Midwife
Other areas of specialty/work
Street address
Reproductive Health research center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
fatemehdalil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)