Protocol summary

Summary
Objectives: To compare the induction of ovulation and pregnancy with letrozole and clomiphene and combination therapy in polycystic ovary syndrome. Design: Cohort prospective intervention.setting: Shahid Akbar Abadi. Inclusion criteria: women with a history of infertility for more than one year and which were diagnosed with anovulation and polycystic ovary syndrome in 2003 based on the revised criteria. Exclusion criteria: women more than 40 and less than 20 years old, pipes anatomical problems approved by HSG, partner impaired sperm analysis based on a modified World Health Organization criteria, such as hypo- or hyperthyroidism; endocrine problems, Hyperprolactinemia; karyotype abnormalities. Intervention: 450 patients that were randomized with non-probabilistic methods available are divided into three groups of 150. Group A, B, C, respectively, treated with 100 mg clomiphene, letrozole 5 mg and 100 mg clomiphene citrate with letrozole 5 mg from the third day of menstural cycle for 5 days. Transvaginal sonography will be performed in 11th day of menstural cycle to evaluate of ovolation. The number of mature follicles, endometrial thickness, the presence of pregnancy, multiple pregnancies and abortions will be recorded under 20 weeks. The main outcome variables: the presence of ovulation, endometrial thickness, the presence of pregnancy, the number of mature follicles.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100223621N4
Registration date: 2016-01-10, 1394/10/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-10, 1394/10/20
Registrant information
Name
Mahnaz Ashrafi
Name of organization / entity
Iran University Of Medical Sciences, Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 3244
Email address
ashrafi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy rate with clomiphene citrate and letrosole and clomiphene alone in infertile patients with polycystic ovary syndrome
Public title
Evaluation of The effect of clomiphene or letrozole in the treatment of infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with history of infertility more over than one year and diagnosis of PCOS based on the revised 2003 . Exclusion criteria: Women older than 40 years or younger than 20; fallopian tubes abnormality proved by hysterosalpingography; abnormal semen analysis for their partners according to the modified criteria of the World Health Organization; endocrine problem like hyper or hypo thyroidism, hyperprolactinemia; abnormal karyotype.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 450
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope

Secondary Ids

1

Registry name
Mahnaz Ashrafi
Secondary trial Id
94-02-30-25979
Registration date
1394-03-02, 773/01/-17

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Iran Univercity of Medical Sciences
Street address
Tehran,Iran univercity
City
Tehran
Postal code
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
IR.IUMS.REC.1394 .25979

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
Ovulation
Timepoint
Day 11 of the Menstrual cycle
Method of measurement
Transvaginal sonography

2

Description
Pregnancy
Timepoint
After retard of mense
Method of measurement
Pregnancy test by missuring B-hCG

3

Description
The number of follicles
Timepoint
Day 11 of the menstrual cycle
Method of measurement
Transvaginal sonography

4

Description
Follicle size
Timepoint
Day 11 of the menstrual cycle
Method of measurement
Transvaginal sonography

5

Description
Endometrial thickness
Timepoint
Day 11 of menstural sicle
Method of measurement
Trans aginal sonography

Secondary outcomes

1

Description
Multiple pregnancies
Timepoint
4-6 weeks after menstural delay
Method of measurement
Pregnancy sonography

2

Description
Abortions under 20 weeks
Timepoint
After pegnancy
Method of measurement
Pregnancy sonography

Intervention groups

1

Description
100 mg daily clomiphene(Ovumid; Iran Hormone, Tehran, Iran) , the third day of menstruation to 5 days
Category
Treatment - Drugs

2

Description
5 mg letrozole (Letrozole 2.5 ; SOHA Pharmaceutical Co, Tehran, Iran) daily, the third day of menstruation to 5 days
Category
Treatment - Drugs

3

Description
100 mg daily clomiphene(Ovumid; Iran Hormone, Tehran, Iran) , the third day of menstruation to 5 days + 5 mg letrozole (Letrozole 2.5 ; SOHA Pharmaceutical Co, Tehran, Iran) daily, the third day of menstruation to 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
AkbarAbadi Hospitall
Full name of responsible person
Dr Sara Gharehsheikhlou
Street address
Akbar Abadi Hospitall
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran Univercity of Medical Sciences
Full name of responsible person
Dr Seid Ali Javad Mousavi
Street address
Iran Univercity of Medical Sciences, Shahid Hemmat highway, 5th floor
City
Tehran
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 Iran Univercity 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
Iran University of Medical Sciences
Full name of responsible person
Dr Sara Ghareh Sheikhlou
Position
Resident of Obstetrical and Gynocology
Other areas of specialty/work
Street address
Akbar Abadi hospital, Molavi St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
sara_sheikhlou@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran Univercity of Medical Sciences
Full name of responsible person
Dr. Mahnaz Ashrafi
Position
Associate Professor
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Molavi St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
ashrafim@royaninstitute.org
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr Sara Gharehsheikhlou
Position
Resident of OB/GYN
Other areas of specialty/work
Street address
Akbar Abadi Hospital, Molavi St, Tehran, Iran
City
Tehran
Postal code
Phone
002155633244
Fax
Email
sara_sheikhlou@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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