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Trial registered on ANZCTR


Registration number
ACTRN12614000025639
Ethics application status
Approved
Date submitted
16/12/2013
Date registered
9/01/2014
Date last updated
12/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Sequential letrozole and human menopausal gonadotropins (HMG) : The effect of a novel super ovulation protocol on pregnancy rate in polycystic ovarian syndrome patients undergoing intracytoplasmic sperm injection. Randomized Controlled Trial
Scientific title
Sequential administration of letrozole and Human Menopausal gonadotropins (HMG) improves the pregnancy rate in polycystic ovarian syndrome ( PCOS) patients treated with intracytoplasmic sperm injection ( ICSI ) – a randomized controlled trial
Secondary ID [1] 283567 0
No
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary syndrome 290472 0
Condition category
Condition code
Reproductive Health and Childbirth 290864 290864 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Induction of ovulation will be done by letrozole tablets 5 mg mg /day from day 2 to day 6 of the participant's menstrual cycle then human menopausal gonadotropins ( HMG ) ampoules (fostimon ;IBSA) ( 150-225 IU /day ) will be given intramuscular according to patients response started from day 7 of menstrual follow till the day of human chorionic gonadotropin (HCG) -which is a hormone similar to endogenous lutienizing hormone to trigger ovulation-in a dose of 10000 iu intramuscular when the dominant follicle reaches 17 mm .
ovum pick up for Intracytoplasmic sperm injection (ICSI ) will be done 34-36 hours after HCG adminstration.
Intervention code [1] 288261 0
Treatment: Drugs
Comparator / control treatment
Induction of ovulation will be done by HMG ampoules(fostimon ; IBSA) alone using a dose of 150- 225 IU / day intramuscular injection and tailored according to patient’s response starting from the second day of the natural or induced menstrual flow till the day of human chorionic gonadotropin (HCG) that will be given in a dose of 10000 iu intramuscular when the dominant follicle reaches 17 mm .
ovum pick up for ICSI will be done 34-36 hours after HCG adminstration.
Control group
Active

Outcomes
Primary outcome [1] 290860 0
the number of oocytes obtained through ovum pickup by transvaginal ultrasound guided aspiration through identification of oocyte under microscopy after ovum pickup
Timepoint [1] 290860 0
Approximately 34 - 36 hours after HCG administration
Primary outcome [2] 290861 0
the number of mature oocytes through assessment of maturity criteria under microscopy using first polar body assessment
Timepoint [2] 290861 0
1-2 hours after ovum pick up
Secondary outcome [1] 305482 0
Gonadotropins dosage and duration of induction ( composite outcome ) dated from the start of ovulation induction until the day of HCG and from number of days we will calculate the total dose of gonadotropins by muliplying the dose per day by the number of days .
Timepoint [1] 305482 0
from the start of induction to be monitored very 2-3 days until the day of HCG administration
Secondary outcome [2] 305483 0
fertilization rate ( the number fertilized oocytes divided by the number of injected mature oocytes)
Timepoint [2] 305483 0
18-24 hours after oocyte pickup
Secondary outcome [3] 305484 0
number of embryos assessed under microscopy
Timepoint [3] 305484 0
at day three of ovum pickup
Secondary outcome [4] 305485 0
grades of embryos through scoring of embryos using the fragmentation percentage , equality of the cells and number of cells in embryos (8 cells at day 3 )
Timepoint [4] 305485 0
at day 3 post ovum pickup
Secondary outcome [5] 305486 0
chemical pregnancy rates by measuring serum quantitative HCG level
Timepoint [5] 305486 0
14 days after oocyte pickup (as mentioned before oocyte pickup done after 34-36 of HCG adminstration)
Secondary outcome [6] 305487 0
clinical pregnancy rate through visualization of cardiac pulsation
Timepoint [6] 305487 0
6-8 weeks after oocyte pickup(as mentioned before oocyte pickup done after 34-36 og HCG adminstration)

Eligibility
Key inclusion criteria
PCOS complaining of infertility
age between 20-35 years.
normal semen analysis according to WHO criteria
Minimum age
20 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
female with a previous history of pelvic surgery
endometriosi.
females with a previous history of failed ICSI

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 by 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 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
by calculating the power of the study statistically beside the estimation of number of cases seen clinically .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5579 0
Egypt
State/province [1] 5579 0

Funding & Sponsors
Funding source category [1] 288251 0
Self funded/Unfunded
Name [1] 288251 0
Address [1] 288251 0
port saeed street alexandria egypt
Elshatby maternity university hospital
21526
Country [1] 288251 0
Egypt
Primary sponsor type
University
Name
alexandria university , faculty of medicine
Address
22 elgeish street , elshatby
Alexandria , egypt
21526
Country
Egypt
Secondary sponsor category [1] 286968 0
None
Name [1] 286968 0
Address [1] 286968 0
Country [1] 286968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290314 0
ethical committe , faculty of medicine ,alexandria university
Ethics committee address [1] 290314 0
Champollion Street

El-Khartoum Square

Azarita Medical Campus alexandria egypt
21526
Ethics committee country [1] 290314 0
Egypt
Date submitted for ethics approval [1] 290314 0
Approval date [1] 290314 0
27/11/2013
Ethics approval number [1] 290314 0
IRB 00007555-fwa no : 00015712

Summary
Brief summary
a new induction protocol for polycyctic ovary syndrome patients complaining of inability to concieve that hopefully will lead to improvement of pregnancy rate
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44206 0
Dr ahmed fawzy galal
Address 44206 0
Elshatby maternity university hospital
port saeed street
alexandria Egypt
21526
Country 44206 0
Egypt
Phone 44206 0
+201222286962
Fax 44206 0
Email 44206 0
galal_af@yahoo.com
Contact person for public queries
Name 44207 0
Dr ahmed fawzy galal
Address 44207 0
Elshatby maternity university hospital
port saeed street
alexandria Egypt
21526
Country 44207 0
Egypt
Phone 44207 0
+201222286962
Fax 44207 0
Email 44207 0
galal_af@yahoo.com
Contact person for scientific queries
Name 44208 0
Dr ahmed fawzy galal
Address 44208 0
Elshatby maternity university hospital
port saeed street
alexandria Egypt
21526
Country 44208 0
Egypt
Phone 44208 0
+201222286962
Fax 44208 0
Email 44208 0
galal_af@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary