This study was conducted with the aim of comparison the pregnancy rate with clomiphen citrate and letrozole in women with poly-cystic ovarian syndrome.
Design
Phase 2-3 clinical trial with parallel groups which was conducted on 80 women with polycystic ovarian syndrome
Settings and conduct
This study was conducted with the aim of comparison the pregnancy rate with clomiphen citrate and letrozole on 80 women with poly-cystic ovarian syndrome. Patients were randomly assigned into two groups; group 1 receiving 100 mg clomiphen citrate orally and group 2 receiving 10 mg letrozole orally. In both groups the drugs were given on days 3-5 of the mensturation cycle. 1 month after giving the drugs, in both groups the pregnancy rate was determined by measuring the B-HCG serm level and compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria: one-year infertility; normal semen analysis in the husband
Exclusion criteria: thyroid dysfunction; fallopian tube or uterine cavity abnormalities
Intervention groups
Intervention group 1:Receiving 10 mg letrozole orally on days 3-5 of the menstruation cycle
Intervention group 2:Receiving 10 mg letrozole orally on days 3-5 of the menstruation cycle
Main outcome variables
Pregnancy Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180602039952N2
Registration date:2018-10-26, 1397/08/04
Registration timing:retrospective
Last update:2018-10-26, 1397/08/04
Update count:0
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Farahnaz Farzaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5744
Email address
f.farzaneh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-12, 1397/06/21
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-09-22, 1397/06/31
Scientific title
Comparison of the pregnancy rate with clomiphen citrate and letrozole in women with poly-cystic ovarian syndrome
Public title
Pregnancy rate with clomiphen citrate and letrozole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
One-year infertility
Normal semen analysis in the husband
Exclusion criteria:
Thyroid dysfunction
Fallopian tube or uterine cavity abnormalities
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10.
The patients were randomly assigned into 2 groups of 40. Considering the sample size of 80 ( 40 patients in letrozole group and 40 patients in clomiphen citrate group) , 8 blocks with 10 people were selected; in each block there was 5 cards of letrozole group and 5 cards of clomiphen citrate group. So by selecting each block, 5 people were assigned into each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study author and data analyzer were not aware of the patients assignment into study groups
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, Dr Hesabi sq., Daneshgah Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2016-09-25, 1395/07/04
Ethics committee reference number
IR.ZAUMS.REC.1395. 47
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Pregnancy rate
Timepoint
1 month after giving the drugs
Method of measurement
By measuring the serum level of B-HCG using DiaPlus B-HCG STAT kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Receiving 100 mg clomiphen citrate orally on days 3-5 of the mensturation cycle
Category
Treatment - Drugs
2
Description
Intervention group 2:Receiving 10 mg letrozole orally on days 3-5 of the mensturation cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Farahnaz Farzaneh
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
f.farzaneh@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
محسن طاهری
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
Farahnaz Farzaneh
Position
Assistant professor
Latest degree
Specialist
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
9816743463
Phone
+98 54 3329 5744
Email
f.farzaneh@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Assistant professor
Latest degree
Specialist
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
9816743463
Phone
+98 54 3329 5744
Email
f.farzaneh@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Assistant professor
Latest degree
Specialist
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
9816743463
Phone
+98 54 3329 5744
Email
f.farzaneh@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available