Objective: to evaluate the efficacy of Letrozole in induction of ovulation in Clomiphene Citrate (CC)- resistant patients and to compare Letrozole responders with non responders. Inclusion criteria: age 18-39, infertility more than 2 years, normal Thyroid Stimulating Hormone (TSH), spermogram and prolactin and normal Follicle-stimulating hormone ( FSH) in the beginning of folicular phase. Exclusion criteria: history of pelvic surgery, presence of adhesions in laparoscopy or hystrosalpingography and presence of any infertility factors except anovulation. Sample size and population under study: 30 patients who referred to Qazvin infertility clinic with polycystic ovary syndrome ( PCOS ) and unexplained infertility who were resistant to CC. Two months after Clomiphen treatment, Letrozole was given in doses of 2/5 – 7/5 mg (depending on patient response; overall 72 cycles) on days 5- 9 of the menstrual cycle. Follicular size was measured by serial vaginal sonography by a specific person followed by administration of Human Chorionic Gonaditropin ( hcG ) if follicle > 18 millimeter was detected. Ovulation and pregnancy rate and endometrial thickness on day of hcG adminstration were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010174868N2
Registration date:2011-01-31, 1389/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Khadijeh Elmizadeh
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 6001
Email address
khelmizadeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Letrozole induction of ovulation in infertile women with Clomiphene resistance
Public title
The effect of Letrozole on Clomiphene resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-39, infertility more than 2 years, normal Thyroid Stimulating Hormone (TSH), spermogram and prolactin and normal Follicle-stimulating hormone (FSH) in beginning of follicular phase. Exclusion criteria: history of pelvic surgery, presence of adhesions in laparoscopy or hystrosalpingography and presence of any infertility factors except anovulation.
Age
From 20 years old to 37 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Vice Chancellor for Research, Qazvin University of Medical Science
City
Qazvin
Postal code
Approval date
1387-03-08, 769/01/-1107
Ethics committee reference number
28/20/1278
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
presence and number of dominant follicles
Timepoint
4 days after the end of treatment
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
pregnancy
Timepoint
26 days after treatment
Method of measurement
presence of gestational sac in vaginal sonography
Intervention groups
1
Description
Oral letrozol in doses of 2/5, 5and 7.5 mg (depending on patient response; overall 72 cycles) higher dose was administered to the patients who did not have mature follicle with lower dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Infertility Clinic
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Qazvin University of Medical Sciences
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Khadijeh Elmizadeh
Position
Obstetrician & Ghynecologist
Other areas of specialty/work
Street address
Kosar Hospital, Taleghani St.
City
Qazvin
Postal code
Phone
+98 28 1223 6380
Fax
Email
khelmizadeh@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Khadijeh Elmizadeh
Position
Obstetrician & Ghynecologist
Other areas of specialty/work
Street address
Kosar Hospital, Taleghani St.
City
Qazvin
Postal code
Phone
+98 28 1334 7280
Fax
Email
khelmizadeh@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)