Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000639921
Ethics application status
Approved
Date submitted
22/06/2011
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between two clomiphene citrate protocols for induction of ovulation in clomiphene resistant Polycystic ovarian disease.
Scientific title
Comparison between two clomiphene citrate protocols for induction of ovulation in clomiphene resistant Polycystic ovarian disease.
Secondary ID [1] 262430 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic ovarian disease. 268119 0
Resistant Anovulation 268136 0
Condition category
Condition code
Reproductive Health and Childbirth 268267 268267 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
clomiphene citrate oral tablets 100 mg daily for 10 days, starting within 5 days of induced menses.
Intervention code [1] 266802 0
Treatment: Drugs
Comparator / control treatment
control group clomiphene citrate oral tablets 200 mg daily for 5 days, starting within 5 days of induced menses.
Control group
Dose comparison

Outcomes
Primary outcome [1] 268992 0
ovulation detected by transvaginal follicle scanning, and serum progesterone value.
Timepoint [1] 268992 0
after the end of treatment
Secondary outcome [1] 276770 0
chemical pregnancy by serum HCG assay.
Timepoint [1] 276770 0
after the end of cycle
Secondary outcome [2] 276787 0
clinical pregnancy by ultrasonography.
Timepoint [2] 276787 0
2 weeks after serum pregnancy test.

Eligibility
Key inclusion criteria
married, nulligravida, polycystic ovarian disease, resistant to clomiphene citrate drug in previous cycle/s
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
previous pelvic surgery, other causes of infertility, BMI>35

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)
Evaluation of eligibility, informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization using computer generated tables, results kept in sealed envelopes till the time of starting treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3637 0
Egypt
State/province [1] 3637 0

Funding & Sponsors
Funding source category [1] 267278 0
Self funded/Unfunded
Name [1] 267278 0
Country [1] 267278 0
Egypt
Primary sponsor type
Individual
Name
Mervat Sheikh Elarab Elsedeek Omran
Address
649 Elhorreya street, Janaclis, Elraml District, Alexandria Egypt.
post code 03312
Country
Egypt
Secondary sponsor category [1] 266338 0
None
Name [1] 266338 0
Address [1] 266338 0
Country [1] 266338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269272 0
The ethics committee of Alexandria faculty of medicine, Alexandria university.
Ethics committee address [1] 269272 0
Alexandria faculty of Medicine, Elraml district, Alexandria, Egypt. post code 03312
Ethics committee country [1] 269272 0
Egypt
Date submitted for ethics approval [1] 269272 0
Approval date [1] 269272 0
29/05/2008
Ethics approval number [1] 269272 0

Summary
Brief summary
The primary purpose of the study is to test if either doubling the dose of clomiphene citrate or doubling the duration would make previously unresponsive patients respond and ovulate, and to compare the efficacy of either approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32764 0
Address 32764 0
Country 32764 0
Phone 32764 0
Fax 32764 0
Email 32764 0
Contact person for public queries
Name 16011 0
Mervat Sheikh elarab Elsedeek
Address 16011 0
649 Elhorreya street, Janaclis, Elraml District, Alexandria Egypt.
post code 03312
Country 16011 0
Egypt
Phone 16011 0
+203 5759915
Fax 16011 0
Email 16011 0
[email protected]
Contact person for scientific queries
Name 6939 0
Mervat Sheikh elarab Elsedeek
Address 6939 0
649 Elhorreya street, Janaclis, Elraml District, Alexandria Egypt.
post code 03312
Country 6939 0
Egypt
Phone 6939 0
+203 5759915
Fax 6939 0
Email 6939 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
SourceTitleYear of PublicationDOI
Dimensions AIComparison between two clomiphene citrate protocols for induction of ovulation in clomiphene resistant polycystic ovary syndrome2014https://doi.org/10.1016/j.mefs.2013.05.012
N.B. These documents automatically identified may not have been verified by the study sponsor.