Protocol summary

Summary
In this study 60 infertile patients referred to infertility research center of Motazedi hospital are studied. All the women should have at least 12 months of unprotected coitus. They undergo a fecundity survey including medical record, physical examination and basal vaginal sonography in the third day of menstruation cycle. Other parameters such as mid luteal phase serum progesterone level, semen analysis of the partner, third day serum FSH and LH level are measured and hysterosalpingography are done to exclude tubal factor. The patients are considered to have unexplained infertility when there are no other etiologies for infertility and these women are entered the study. In the third day of the cycle, basal TVUS is done to study uterine and adnexa and to measure the endometrial thickness. In control group 100 mg of Clomiphen citrate is given in Single dose for 5 days parenterally from days 3-7 of menstruation cycle and in case group Anastrozole tab 1mg will be given in single dose for 3 days parenterally from days 3-5 menstruation cycle. In both groups injectable HMG (gonal F/IM/ Serono …) will be prescribed from days 6-9 with constant dose of 75 units. In the 9th of the cycle a second vaginal sonography is done and in case of inappropriate response (follicle less than 17mm in diameter) injectable HMG is continued till a mature follicle is obtained.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810193028N1
Registration date: 2009-05-22, 1388/03/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-05-22, 1388/03/01
Registrant information
Name
Taravat Fakheri
Name of organization / entity
Maternity Research center, Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6309
Email address
tfakheri@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of Clomiphene citrate and short course Anastrozole in intrauterine insemination cycles
Public title
A comparative study of Clomiphene citrate and short course Anastrozole in intrauterine insemination cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) to have at least 12 months of infertility; 2) unexplainable infertility; 3) regular period cycles between 21 to 35 days. Exclusion Criteria: 1) women younger than 18 and older than 38 years old; 2) anovulation; 3) prior ART cycles; 4) systemic diseases such as endometriosis, persistent ovarian cyst and malignancies of breast, ovary and uterine. Basic alternatives such as age and BMI are measured and both groups regarding the alternatives will be matched.
Age
From 18 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Kermanshah University of Medical Sciences
Street address
Obs & Gynecology department, Imam Reza Hospital, Parastar Blvd
City
Kermanshah
Postal code
67144-15333
Approval date
empty
Ethics committee reference number
پ/7/420/2613

Health conditions studied

1

Description of health condition studied
Unexplained infertile women undergoing IUI treatment
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified

Primary outcomes

1

Description
Numbers and size of adult foliclles after one treatment cycle
Timepoint
In every stimulation cycle , in the Ninth day of cycle
Method of measurement
By means of vaginal sonography

Secondary outcomes

1

Description
Thickness of endometerium after a period of treatment
Timepoint
In every ovulatory cycle in the ninth day of cycle
Method of measurement
By means of vaginal sonography

Intervention groups

1

Description
In case group: Anastrozole tablets 1 mg / once daily/ for three days, from days3-5 of menstrual cycle and followed by gonadotropines from days 6-8
Category
Treatment - Drugs

2

Description
In control group: Clomiphene citrate tablets 50 mg orally, two tablets per day, from days 3-7 and followed by gonadotropins from days 6-8
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Research Center of Motzedi Hospital
Full name of responsible person
Dr. Taravat Fakheri
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences (KUMS )
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah University of Medical Sciences (KUMS ).
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences (KUMS )
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 ( KUMS)
Full name of responsible person
Dr, Taravat Fakheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Obs & Gynecology department, Imam Reza Hospital, Parastar Blvd, Sorkheh Lyjeh
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1427 6310
Fax
Email
fakheritaravats@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences ( KUMS)
Full name of responsible person
Dr.Salma Hosseini
Position
Resident
Other areas of specialty/work
Street address
Obs & Gynecology department, Imam reza hospital, Parastar blvd, Sorkheh lyjeh
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1427 6310
Fax
Email
sara_daee@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences ( KUMS)
Full name of responsible person
Sara Daei Chin
Position
Obstetrics ( BCs) Of Maternity Research Center
Other areas of specialty/work
Street address
Obs & Gynecology department,Imam Reza Hospital,Parastar Blvd,Sorkheh Lyjeh,Kermanshah University of Medical Sciences ( KUMS) , Kermanshah
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1427 6310
Fax
+98 83 1427 6355
Email
sara_daee@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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