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Trial registered on ANZCTR


Registration number
ACTRN12614000024640
Ethics application status
Approved
Date submitted
16/12/2013
Date registered
9/01/2014
Date last updated
9/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Letrozole step-up protocol: the effect of a noval superovualtion induction protocol to enhance pregnancy rate in a couple with unexplained infertility undergoing intrauterine inssemination.
Scientific title
Letrozole step-up protocol: the effect of a noval superovualtion induction protocol to enhance pregnancy rate in a couple with unexplained infertility undergoing intrauterine inssemination.
Secondary ID [1] 283781 0
301/26 faculty of medicine alexandria university
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unexplained infertility 290757 0
Condition category
Condition code
Reproductive Health and Childbirth 291118 291118 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
prospective randomized trial that included 100 couples with unexplained infertility agreed to continue with intrauterine inssemination (IUI )
All participants were extensively counseled about the risks and benefits of each type of treatment and an informed consent was obtained. 50 Patients received a daily dose of letrozole (Femara; Novartis) tablets orally beginning on day 3 of menstrual cycle with 2.5 mg (1 tab) which is then increased in a step up fashion to 5 mg (2 tabs), 7.5 mg (3 tabs) and finally 10 mg (4 tabs) on days 4, 5 and 6 of the menstrual cycle (Total duration of treatment will be four days starting from third day of mensis).
all participants of this group will be followed up by transvaginal ultrasonography starting from day 7 menstrual cycle every 3 days until one dominant follicle reaches a size of 17 mm hence HCG will be given intramuscular in a dose of 10000 iu followed by IUI 36 hours later .
Intervention code [1] 288467 0
Prevention
Comparator / control treatment
Patients in control group will receive human menopausal gonadotropins preparation (HMG ) as (fostimon / merional; IBSA)

HMG injection will be given daily in a dose of 75 iu (1 ampoule) from day 3 of the menstrual cycle that will be tailored according to the response assessed by vaginal ultrasoound every three days until one dominant follicle reach a size of 17 mm ,hence HCG will be given intramuscular in a dose of 10000 iu followed by IUI 36 hours later .
Control group
Active

Outcomes
Primary outcome [1] 291101 0
ongoing pregnancy rate through detection of pulsating interuterine gestational sac by vaginal ultrasound at 6-8 weeks of gestation
Timepoint [1] 291101 0
defined as detection of viable gestational sac at 6 to 8 weeks gestation
Primary outcome [2] 291102 0
number of mature follicles that are defined as a follicle measurement more than 17 mm by vaginal ultrasound
Timepoint [2] 291102 0
at the day of human chorionic gonadotropins injection (HCG)
Primary outcome [3] 291103 0
endometrial thickness by enovaginal utrasound at the day of HCG administration.
With the uterus imaged in the longitudinal plan, endometrial thickness will be measured at the thickest point between the two basal layers on the anterior and posterior uterine walls. Endometrial thickness, measured to the nearest millimeters, included both endometrial layers together
Timepoint [3] 291103 0
at the day of HCG
Secondary outcome [1] 306003 0
ovarian hyperstimulation syndrome assessed by endovaginal ultrasound visualization of large cystic ovary and measurement of serum estradiol level
Timepoint [1] 306003 0
early after HCG administration till pregnancy if occurred through monitoring of patient complain of abdominal fullness , vomiting and ultrasound assessment of ovarian size in addition to serum estradiol serum assessment .
Secondary outcome [2] 306004 0
total financial cost of the cycle treatment
Timepoint [2] 306004 0
after finishing treatment and doing intrauterine insemination procedure

Eligibility
Key inclusion criteria
couples with unexplained infertility
All men had to have a normal semen analysis according to World Health Organization (WHO) criteria
age from 20-35 years.
Bilateral tubal patency .
indicated and Consenting to do IUI .
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
previous history of pelvic surgery
endometriosis,

females with a previous history of failed iui

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
centeral randomization using computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
through assessment of eligible clinical cases attending the clinic and power calculation and sample size calculation of statistician

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2014
Actual
Date of last participant enrolment
Anticipated
15/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5681 0
Egypt
State/province [1] 5681 0
alexandria

Funding & Sponsors
Funding source category [1] 288440 0
Self funded/Unfunded
Name [1] 288440 0
Country [1] 288440 0
Primary sponsor type
University
Name
alexandria university , faculty of medicine
Address
22 elgeish street , elshatby 21526
Alexandria
Country
Egypt
Secondary sponsor category [1] 287142 0
None
Name [1] 287142 0
Address [1] 287142 0
Country [1] 287142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290315 0
ethical committe , faculty of medicine ,alexandria university
Ethics committee address [1] 290315 0
Ethics committee country [1] 290315 0
Egypt
Date submitted for ethics approval [1] 290315 0
Approval date [1] 290315 0
27/11/2013
Ethics approval number [1] 290315 0
IRB 00007555-fwa no : 00015712

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44986 0
Dr ahmed fawzy galal
Address 44986 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21526
Country 44986 0
Egypt
Phone 44986 0
+201222286962
Fax 44986 0
Email 44986 0
galal_af@yahoo.com
Contact person for public queries
Name 44987 0
ahmed fawzy galal
Address 44987 0
Elshatby maternity university hospital port saeed street alexandria Egypt 21516
Country 44987 0
Egypt
Phone 44987 0
+201222286962
Fax 44987 0
Email 44987 0
galal_af@yahoo.com
Contact person for scientific queries
Name 44988 0
ahmed fawzy galal
Address 44988 0
Elshatby maternity university hospital port saeed street alexandria Egypt
21526
Country 44988 0
Egypt
Phone 44988 0
+201222286962
Fax 44988 0
Email 44988 0
galal_af@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.