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Trial registered on ANZCTR


Registration number
ACTRN12608000225314
Ethics application status
Approved
Date submitted
24/04/2008
Date registered
1/05/2008
Date last updated
7/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does luteal estradiol supplementation have a role in long agonist cycles?"
Scientific title
In intracytoplasmic sperm injection (ICSI) cases using long gonadotropin releasing hormone (GnRH) agonist protocol, does the use of vaginal etradiol luteal supplementation compared to oral estradiol supplementation or propgesterone alone improve luteal hormonal profile or pregnancy rate?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 3083 0
Condition category
Condition code
Reproductive Health and Childbirth 3240 3240 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular (IM) progesterone 100 mg/day starting on day of ET till 8 weeks of gestation + Vaginal application of estradiol valerate tablets 2mg 3 times/day starting on day of embryo transfer (ET) throughout the whole luteal phase. The complete duration of the study is 25 months.
Intervention code [1] 2824 0
Treatment: Drugs
Comparator / control treatment
1- IM progesterone 100mg/day alone starting on day of ET till 8 weeks of gestation 2- IM progesterone 100mg/day starting on day of ET till 8 weeks of gestation + Oral estradiol valerate 2mg 3 times/day starting on day of ET throughout the whole luteal phase.
Control group
Active

Outcomes
Primary outcome [1] 4123 0
Clinical pregnancy by assessing clinical pregnancy rate
Timepoint [1] 4123 0
Human chorionic gonadotrophin (hCG) testing on day 16 and 18 after ET, Ultrasound 3 weeks after +ve hCG testing
Secondary outcome [1] 6940 0
Luteal serum estradiol and progesterone levels by electrochemiluminescence immunoasays
Timepoint [1] 6940 0
Day of human chorionic gonadotropin (hCG) administration (day 0), +7, +10 and +13

Eligibility
Key inclusion criteria
Women undergoing intracytoplasmic sperm injection due to male factor of infertility using pituitary desensitization by GnRH agonist long protocol
Minimum age
No limit
Maximum age
37 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age > 37 years, body mass index (BMI) < 18 or > 29, irregular menstral cycles, women with single ovary, day 3 serum follicle stimulating hormone (FSH) 9.5 milli international units (mIU)/ml or more, basal antral follicle count 6 or less, 5 or less retreived mature follicles, non availability of good quality embryos and failure to obtain a written consent.

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)
After ensuring eligibility and agreement to participate, participants were sent to the unit pharmacy where each participant was asked to select one sealed envelope only once to determine the group to which she will be assigned. The randomization key was kept with the pharmacy director and was not opened until after statistical analysis
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization method
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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] 951 0
Egypt
State/province [1] 951 0

Funding & Sponsors
Funding source category [1] 3335 0
Self funded/Unfunded
Name [1] 3335 0
Address [1] 3335 0
Country [1] 3335 0
Egypt
Primary sponsor type
Individual
Name
Eman Amin Elgindy
Address
Cairo, Rehab city, group 60, building 11, apart 22.
Country
Egypt
Secondary sponsor category [1] 2981 0
Individual
Name [1] 2981 0
Dahlia Osman El-Haieg
Address [1] 2981 0
Cairo, Maadi, 104 street, no 110
Country [1] 2981 0
Egypt

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 28549 0
Address 28549 0
Country 28549 0
Phone 28549 0
Fax 28549 0
Email 28549 0
Contact person for public queries
Name 11706 0
Dahlia Osman El-Haieg
Address 11706 0
Cairo, Maadi, 104 street, no 110
Country 11706 0
Egypt
Phone 11706 0
020225263936
Fax 11706 0
Email 11706 0
drdalia65@hotmail.com
Contact person for scientific queries
Name 2634 0
Eman Amin Elgindy
Address 2634 0
Cairo, Rehab city, group 60, building 11, apart 22
Country 2634 0
Egypt
Phone 2634 0
020226922453
Fax 2634 0
020552321677
Email 2634 0
eman_elgindy@hotmail.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