Comparison the effect of letrozole and dexamethasone with letrozole alone on ovarian response in infertile women
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 120 infertile women.
Settings and conduct
This study will be conducted with the aim of comparison the effect of letrozole and dexamethasone with letrozole alone on ovarian response in 120 infertile women. After inclusion in the study, using block randomization with quadrilateral blocks method the patients will be assigned into two groups; letrozole plus dexamethasone group and letrozole-only group. In both groups 10 mg letrozole will be given form the days 3-5 of the cycle for 5 days and the dexamethasone will be given 0.5 mg orally from the day 4 to 15 of the cycle. Finally, in days 12-14 of the cycle the follicle diameter and endometrial thickness will be measured by trans-vaginal ultrasonography and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all infertile women with polycystic ovarian syndrome; age 18-39 years
Exclusion criteria: Using corticosteroid drugs; history of surgery on ovaries; endocrine abnormalities such as thyroid gland disorders
Intervention groups
Intervention group 1: Letrozole 10 mg form the days 3-5 of the cycle for 5 days plus 0.5 mg oral dexamethasone from the day 4 to 15 of the cycle
Intervention group 2: Letrozole 10 mg form the days 3-5 of the cycle for 5 days
Main outcome variables
Follicle diameter
Endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180318039129N1
Registration date:2018-03-27, 1397/01/07
Registration timing:prospective
Last update:2018-03-27, 1397/01/07
Update count:0
Registration date
2018-03-27, 1397/01/07
Registrant information
Name
Fatemeh Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
dr.f.afshar@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of letrozole and dexamethasone with letrozole alone on ovarian response in infertile women
Public title
The effect of letrozole and dexamethasone on ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infertile women with polycystic ovarian syndrome
Age 18-39 years
Exclusion criteria:
Using corticosteroid drugs
History of surgery on ovaries
Endocrine abnormalities such as thyroid gland disorders
Age
From 18 years old to 39 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with quadrilateral blocks
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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR. ZAUMS. REC.1396.348
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Follicle diameter
Timepoint
Between the days 12-14 of the cycle
Method of measurement
By trans-vaginal ultrasonography
2
Description
Endometrial thickness
Timepoint
Between the days 12-14 of the cycle
Method of measurement
By trans-vaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Letrozole 10 mg form the days 3-5 of the cycle for 5 days plus 0.5 mg oral dexamethasone from the day 4 to 15 of the cycle
Category
Treatment - Drugs
2
Description
Intervention group 2: Letrozole 10 mg form the days 3-5 of the cycle for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Fatemeh Afshar
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.f.afshar@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Afshar
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.f.afshar@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Afshar
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.f.afshar@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Afshar
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
dr.f.afshar@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available