Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000384752
Ethics application status
Approved
Date submitted
7/03/2013
Date registered
10/04/2013
Date last updated
10/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between different doses of gonadotropin-releasing hormone agonist used in short stimulation protocol in infertile women undergoing IVF
Scientific title
Hormonal responses and clinical outcome following three doses of gonadotropin-releasing hormone agonist used in short stimulation protocol in infertile patients undergoing in vitro fertilization cycles
Secondary ID [1] 281896 0
Nil
Universal Trial Number (UTN)
U1111-1139-2471
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 288296 0
Condition category
Condition code
Reproductive Health and Childbirth 288639 288639 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ovulatory patients undergoing in vitro fertilization cycles will start treatment with intramuscular injection of urinary gonadotropins, 2 ampoules (150 IU) per day and subcutaneous injections of GnRH-a (Triptorelin) on the first day of the menstrual period and continued till the day of human chorionic gonadotropins (hCG) administration. We administered human chorionic gonadotropin (hCG) when at least three follicles of 16 mm or more in diameter and adequate estradiol plasma concentrations were detected. Patients will be randomly assigned to three groups; group A, group B and group C . The daily dose of Triptorelin will be 0.1 mg, 50 ug, and 25 ug in groups A, B and C respectively.'
Intervention code [1] 286461 0
Treatment: Drugs
Comparator / control treatment
Patients will be randomly assigned to three groups; group A, group B and group C . The daily dose of Triptorelin will be 0.1 mg, 50 ug, and 25 ug in groups A, B and C respectively. Group A in which the patients will recieve the routine dose of 0.1 Triptorelin will be the control group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288796 0
Pregnancy rate defined as the detection of rising B human chorionic gonadotropin titre in the serum and the ultrasound diagnosis of intruterine gestational sac.
Timepoint [1] 288796 0
within four weeks of intervention commencement
Secondary outcome [1] 301008 0
Occurence of LH surge by the measurement of LH level in the serum
Timepoint [1] 301008 0
Within two weeks of intervention commencement

Eligibility
Key inclusion criteria
Infertile patients undergoing in vitrofertilization cycles,
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with ovarian failure

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The demographic data of the patients, hormonal levels, stimulation requirements and outcome variables will be compared for the three groups. Results will be presented as mean +/- standard deviation. Where appropriate, x2 test and t-test will be used for analysis using SPSS for Windows version 11.0 (SPSS Inc., Chicago, IL USA). P<.05 was considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
1/01/2012
Date of last participant enrolment
Anticipated
1/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 4840 0
Egypt
State/province [1] 4840 0

Funding & Sponsors
Funding source category [1] 286686 0
Self funded/Unfunded
Name [1] 286686 0
Country [1] 286686 0
Egypt
Primary sponsor type
Other
Name
Sarhan IVF Cntre
Address
No 10 Alkawmya Street,
11144, Zagazig, Egypt
Country
Egypt
Secondary sponsor category [1] 285457 0
None
Name [1] 285457 0
Address [1] 285457 0
Country [1] 285457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288751 0
Zagazig University Fuculty of Medicine Ethical committee ZU-IRB
Ethics committee address [1] 288751 0
Zagazig Univeersity Faculty of Medicine

11118, Zagazig, Egypt
Ethics committee country [1] 288751 0
Egypt
Date submitted for ethics approval [1] 288751 0
10/05/2011
Approval date [1] 288751 0
15/07/2011
Ethics approval number [1] 288751 0

Summary
Brief summary
Gonadotropin releasing hormone agonist (GnRH-a) is used routinely in controlled ovarian stimulation for assisted reproduction either in its short (flare-up) or long protocol. The routine daily dose of the different agonists was introduced by trials and is not uniformly established.
The objective of this prospective randomized controlled study was to characterize the daily changes in the levels of luteinizing hormone (LH) and estradiol (E2) and to compare the intracytoplasmic sperm injection (ICSI) outcome with 3 different doses of the GnRH-a used in a short protocol for normal ovulatory females.
Patientswill be randomly assigned to three groups; group A (N=34), group B (N=34) and group C (N=23). All the patients will start treatment with urinary gonadotropins, 2 ampoules per day and GnRH-a (Triptorelin) on the first day of the menstrual period and continued till the day of human chorionic gonadotropins (hCG) administration. The daily dose of Triptorelin will be 0.1 mg, 50 ug, and 25 ug in groups A, B and C respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37634 0
Prof Abdulmagid Sarhan
Address 37634 0
Professor/ Abdulmagid Sarhan, Professor Zagazig University
Borg Salma, Talaat Harb Street,
11014, Zagazig, Egypt
Country 37634 0
Egypt
Phone 37634 0
+201227972674
Fax 37634 0
Email 37634 0
sarhan_a@hotmail.com
Contact person for public queries
Name 37635 0
Prof Abdulmagid Sarhan
Address 37635 0
Professor/ Abdulmagid Sarhan, Professor Zagazig University
Borg Salma Talaat Harb Streat,
11014, Zagazig, Egypt
Country 37635 0
Egypt
Phone 37635 0
+201227972674
Fax 37635 0
Email 37635 0
sarhan_a@hotmail.com
Contact person for scientific queries
Name 37636 0
Prof Professor/ Abdulmagid Sarhan
Address 37636 0
Professor/ Abdulmagid Sarhan, Professor Zagazig University
Borg Salma Talaat Harb Street,
11014, Zagazig, Egypt
Country 37636 0
Egypt
Phone 37636 0
+201227972674
Fax 37636 0
Email 37636 0
sarhan_a@hotmail.com

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No Supporting Document Provided



Results publications and other study-related documents

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