Protocol summary

Summary
This study was designed to compare the effectiveness of clomiphene, tamoxifen and letrozole in ovulation induction outcome: number of mature follicles, endometrial thickness, pregnancy rate, multiple pregnancy rate, live birth and miscarriage in isolated non PCOS unovulatory patient. In this prospective randomized clinical trial, 150 infertile women who had isolated nonPCOS unovulation, were randomized to 3 groups. Group A received clomiphene, 50 mg up to 150mg for 5-7days. Group B received tamoxifen 10 mg up to 30mg for 5-7 days and Group C received letrozole 2.5 mg up to 7.5mg for 5-7 days. The drugs have been increased in dose and duration to achieve mature follicle. If the patients were not responding to treatment with maximum dose for 7 days or failed to concept after six months, treatment was discontinued. Main outcome measures were number of follicles ≥18 mm, endometrial thickness and ovulation rate and secondary outcome measures clinical pregnancy rates, spontaneous abortions rates, multiple pregnancies, and ovarian hyperstimulation syndrome (OHSS).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104096152N1
Registration date: 2011-06-07, 1390/03/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-07, 1390/03/17
Registrant information
Name
Fariba Seyedoshohadaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 82 1328 2001
Email address
f.seyedoshohadaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2007-04-21, 1386/02/01
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of clomiphene citrate, tamoxifen and letrozole in ovulation induction in infertility due to isolated unovulation
Public title
Comparison of the effectiveness of clomiphene citrate, tamoxifen and letrozole in ovulation induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women between 15 to 40 years old with infertility due to unovulation who refer to gynecologists, and they have normal semen analysis, hystrosalpingography and evidence of unovulation (include irregular menses and less than 14 mm folicle in sonography) Exclusion criteria: Abnormal gondothrpins (LH, FSH) and prolactin, clinical finding of hyperandrogenism (including acne and hirsutism) and poly cystic appearance in sonography (including ovarian enlargement and subcoticular multiple small cysts)
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kordestan University of Medical Sciences
Street address
Besat Hospital-Keshavarz street-Sanandaj
City
Sanandaj
Postal code
Approval date
2006-06-03, 1385/03/13
Ethics committee reference number
پ/14/پ/5205

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
ovulation
Timepoint
monthly
Method of measurement
sonography

Secondary outcomes

1

Description
Live Birth
Timepoint
after delivery
Method of measurement
postpartum period

2

Description
Pregnancy
Timepoint
after missed period
Method of measurement
serum BHCG measurment

3

Description
Abortion
Timepoint
monthly in first half of pregnancy
Method of measurement
sonography

4

Description
Twin Pregnancy
Timepoint
first prenatal care
Method of measurement
sonography

Intervention groups

1

Description
Group A received clomiphene 50 mg up to 150mg for 5-7days. Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnancy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued.
Category
Treatment - Drugs

2

Description
Group B received tamoxifen 10 mg up to 30mg for 5-7days. Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnancy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued
Category
Treatment - Drugs

3

Description
Group C received letrozole 2.5 mg up to 7.5mg for 5-7days. Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnanvy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
private office of Dr Fariba Seyedoshohadaei
Full name of responsible person
Fariba Seyedoshohadaei MD
Street address
Obestetric &Gynecology Department-Besat Hospital-sanandaj
City
Sanandaj

2

Recruitment center
Name of recruitment center
Private office of Dr Farnaz Zand Vakili
Full name of responsible person
Farnaz Zandvakily MD
Street address
Obestetric &Gynecology Department-Besat Hospital-sanandaj
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kordestan University of Medical Sciences and Health Services
Full name of responsible person
mr.Fardin Garibi
Street address
Kurditan University of Medial Sciences
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kordestan University of Medical Sciences and Health Services
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
Besat Hospital -Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Seyedoshohadaei MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Obestetric &Gynecology Department-Besat Hospital-sanandaj
City
Sanandaj
Postal code
Phone
+98 87 1328 2001
Fax
Email
F.SEYEDOSHOHADAEI@MUK.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences-Besat Hospital
Full name of responsible person
Fariba Seyedoshohadaei MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Obestetric &Gynecology Department-Besat Hospital-sanandaj
City
Sanandaj
Postal code
Phone
+98 87 1328 2001
Fax
Email
F.SEYEDOSHOHADAEI@MUK.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences-Besat Hospital
Full name of responsible person
Fariba Seyedoshohadaei MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Obestetric &Gynecology Department-Besat Hospital-sanandaj
City
Sanandaj
Postal code
Phone
+98 87 1328 2001
Fax
Email
F.SEYEDOSHOHADAEI@MUK.AC.IR
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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