Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000904774
Ethics application status
Approved
Date submitted
8/08/2013
Date registered
13/08/2013
Date last updated
13/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study between cabergoline and intravenous calcium in the prevention of ovarian hyper stimulation in women with polycystic ovarian disease undergoing Intracytoplasmic sperm injection (ICSI ).
Scientific title
Comparative study between cabergoline and intravenous calcium in the prevention of ovarian hyper stimulation in women with polycystic ovarian disease undergoing ICSI .
Secondary ID [1] 282992 0
ElKattan Protocol 100
Issuing authority ,Cairo University
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subfertility
 289817 0
ovarian hyperstimulation 289818 0
Poly cystic ovarian disease 289836 0
Condition category
Condition code
Reproductive Health and Childbirth 290170 290170 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.5 mg oral Tablets cabergoline (Dostinex) daily for 8 days from the day of HCG injection. For once in the trial
To monitor the adherence to the medication we ask the patient for the drug tablet return.
Intervention code [1] 287707 0
Treatment: Drugs
Intervention code [2] 287714 0
Prevention
Comparator / control treatment
intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup.for once in the treatment cycle and each patient will undergo one treatment cycle during the trial.
Control group
Active

Outcomes
Primary outcome [1] 290199 0
The Occurrence of ovarian hyper stimulation which can be diagnosed clinically by patient symptoms accompanied by ultrasonography and laboratory investigation
Timepoint [1] 290199 0
10 months
Primary outcome [2] 290213 0
The severity of ovarian hyper stimulation which is detected by the need for ascitic drainage and the need for hospitalisation
Timepoint [2] 290213 0
10 months
Secondary outcome [1] 304089 0
chemical pregnancy rate :Positive (serum BHCG) 14 days following Embryo transfer
Timepoint [1] 304089 0
10 months
Secondary outcome [2] 304090 0
clinical pregnancy rate: positive pregnancy test and positive fetal heart beat by ultrasound after 6 weeks gestaional age
Timepoint [2] 304090 0
10 months
Secondary outcome [3] 304091 0
miscarriage rate: diagnosed by ultrasound /clinically
Timepoint [3] 304091 0
10 months
Secondary outcome [4] 304092 0
ectopic rate :diagnosed by ultrasound /clinically
Timepoint [4] 304092 0
10 months

Eligibility
Key inclusion criteria
-Subfertile women with polycystic ovarian disease
-serum FSH within normal limits( 1-12IU /l)
-at least 15 follicles or more ,more than 10 mm at the time of HCG administration
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-patients need coasting for high risk of OHSS.
-patients need cycle cancellation.
-severe male infertility requiring testicular sperm extraction.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment is done by central randomisation by the computer .Entry of a woman’s initials, ID number, and date of birth on to a dedicated computer on the clinic, automatically generated the allocation group together with a study number, which was then recorded on the outcome sheet. These data could, if necessary, be verified against the computer randomisation at a later time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
15/07/2013
Date of last participant enrolment
Anticipated
30/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5284 0
Egypt
State/province [1] 5284 0
Cairo

Funding & Sponsors
Funding source category [1] 287761 0
Self funded/Unfunded
Name [1] 287761 0
Eman Elkattan
Country [1] 287761 0
Egypt
Primary sponsor type
Individual
Name
Eman Elkattan
Address
Cairo University Teaching Hospital
1.Kasr AlAini street,Cairo Egypt
Postcode:11562
Country
Egypt
Secondary sponsor category [1] 286487 0
None
Name [1] 286487 0
Address [1] 286487 0
Country [1] 286487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289707 0
Cairo University
Ethics committee address [1] 289707 0
1.Kasr AlAini street
Cairo,Egypt
Postcode:11562
Ethics committee country [1] 289707 0
Egypt
Date submitted for ethics approval [1] 289707 0
Approval date [1] 289707 0
Ethics approval number [1] 289707 0

Summary
Brief summary
we study novel approaches in the management of ovarian hyperstimulation in women suffering with Polycystic ovarian disease (PCO) and undergoing Intracytoplasmic sperm injection (ICSI).we compare the effect of intravenous calcium and oral cabergoline on the severity of ovarian hyperstimulation and outcome of ICSI as regard the pregnancy rate and miscarriage rate
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42070 0
A/Prof Eman Elkattan
Address 42070 0
Cairo University
1.Kasr alAini street,Cairo,Egypt
Postcode:11562
Country 42070 0
Egypt
Phone 42070 0
+20 1222854159
Fax 42070 0
Email 42070 0
[email protected]
Contact person for public queries
Name 42071 0
A/Prof Eman Elkattan
Address 42071 0
Cairo University
1.Kasr alAini street,Cairo ,Egypt
Postcode:11562
Country 42071 0
Egypt
Phone 42071 0
+20 1222854159
Fax 42071 0
Email 42071 0
[email protected]
Contact person for scientific queries
Name 42072 0
A/Prof Eman Elkattan
Address 42072 0
Cairo University
1.Kasr alAini street,Cairo ,Egypt
Postcode:11562
Country 42072 0
Egypt
Phone 42072 0
+20 1222854159
Fax 42072 0
Email 42072 0
[email protected]

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
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