Objectives: Comparison of efficacy of clomiphene citrate and letrozole on ovulation Induction in intrauterine insemination cycles Gradient technique. Design: Randomized, single-blind, single-center, phase II trial. Setting and conduct: For Group A, letrozole pill (dose 2.5 mg) is administered from fifth day of the menstrual cycle for 5 days. For Group B, clomiphene pill (dose 100 mg) is administered from fifth day of the menstrual cycle for 5 days. 13-14 day of menstruation, ovulation and intrauterine is evaluated. Participants including major eligibility criteria: Inclusion criteria include women who are not ovulation; exclusion criteria include irregular use of prescription drug. Intervention: For Group A, letrozole pill (dose 2.5 mg) is administered from fifth day of the menstrual cycle for 5 days. For Group B, clomiphene pill (dose 100 mg) is administered from fifth day of the menstrual cycle for 5 days. Main outcome measures variable: ovulation Induction in intrauterine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031811245N2
Registration date:2016-08-21, 1395/05/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-21, 1395/05/31
Registrant information
Name
Nasrin Jalilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1427 6301
Email address
njalilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study efficacy of clomiphene citrate and letrozole on ovulation Induction in intrauterine insemination cycles Gradient technique
Public title
Efficacy of clomiphene citrate and letrozole on ovulation Induction in intrauterine insemination cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include women who are not ovulation; exclusion criteria include irregular use of prescription drug.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No 1, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.356
Health conditions studied
1
Description of health condition studied
Anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Ovulation of intrauterine
Timepoint
On the 13-14 day of menstruation
Method of measurement
According to transvaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Letrozole, 2.5 mg orally, once daily for 5 days
Category
Treatment - Drugs
2
Description
clomiphene, 2.5 mg orally, once daily for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Nasrin Jalilian
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrozeh Hamzeh
Street address
Building No 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical sciences
Full name of responsible person
Nasrin Jalilian
Position
Specialist in obstetrics and gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
njalilian@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Nasrin Jalilian
Position
Obstetrics and gynecology specialist
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
njalilian@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Anahita Alikhah
Position
Assistant of obstetrics and gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)