Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000150741
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
7/02/2013
Date last updated
7/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
percentage of polycystic ovary syndrome among fertile and infertile Women In Minia Governorate, Egypt
Scientific title
Prevalence Of Polycystic Ovary Syndrome Among Fertile And Infertile Women In Minia Governorate, Egypt
Secondary ID [1] 281888 0
Nil known
Universal Trial Number (UTN)
U1111-1139-2131
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 288288 0
Condition category
Condition code
Reproductive Health and Childbirth 288631 288631 0 0
Fertility including in vitro fertilisation
Metabolic and Endocrine 288647 288647 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prevalence Of Polycystic Ovary Syndrome. Prevalence of PCOS is the proportion of a population found to have a PCOS among study group. Fertile and infertile patients attending infertility clinic fulfilling inclusion and exclusion criteria over 16 months duration were recruited.PCOS was diagnosed by the presence of two or more of the following; clinical and/or biochemical hyperandrogenism, menstrual disorders and polycystic ovaries in transvaginal ultrasound. The clinical assessment of hirsutism is subjective, and it is important to consider the patient’s perception of unwanted hair growth in addition to the perceived rate and timing of hair growth onset. Hirsutism was referred to the growth of coarse, dark hair in areas without hair at all or where fine hair typically grows or, and takes male pattern distribution; above the lip and on the chin, chest, abdomen, and back. Free testosterone (free T) was used to assess hyperandrogenism. Polycystic ovaries were identified by vaginal ultrasound, conducted in the follicular phase or when hormonal assessment showed no follicular activity. A positive finding of polycystic ovaries required either 12 or more follicles measuring 2–9 mm in diameter, or increased ovarian volume (10 cm) in at least one of the ovaries.
Each woman was assessed once.
Intervention code [1] 286451 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288784 0
diagnosis of polycystic ovary syndrome using Rotterdam diagnostic criteria
Timepoint [1] 288784 0
Diagnosis of PCOS was assessed once for each woman at the follicular phase of the menstrual cycle. Each woman was assessed once (Single assessment).
Secondary outcome [1] 300991 0
history of one or more of associated metabolic disorder or other causes of hirsutism.
Timepoint [1] 300991 0
Single assessment at the first interview of the patients (during history taking)

Eligibility
Key inclusion criteria
middle aged female, on IUCD for contraception and her last delivery was for at least 2 years. An inclusion criterion for infertile women was primary or secondary infertility for variable periods i.e. more than one year for primary infertility and two years for secondary infertility without upper limit.
Minimum age
20 Years
Maximum age
37 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnant or breast-feeders, if they did not accept to complete the study steps, if they reported being menopausal, using hormone replacement therapy or hormonal contraception, if they had a hysterectomy or oophorectomy, presence of any other etiologies of androgen excess, known hypothyroid patients and patients missing information about cycle regularity

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
6/02/2010
Date of last participant enrolment
Anticipated
30/04/2011
Actual
26/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1450
Accrual to date
Final
Recruitment outside Australia
Country [1] 4837 0
Egypt
State/province [1] 4837 0
Minia

Funding & Sponsors
Funding source category [1] 286674 0
University
Name [1] 286674 0
Minia University, faculty of Medicine
Country [1] 286674 0
Egypt
Primary sponsor type
University
Name
Minia University
Address
Minia University, Minia, Egypt
Country
Egypt
Secondary sponsor category [1] 285448 0
None
Name [1] 285448 0
Address [1] 285448 0
Country [1] 285448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288740 0
ethical committee of the Department of Obstetrics and Gynecology
Ethics committee address [1] 288740 0
Ethics committee country [1] 288740 0
Egypt
Date submitted for ethics approval [1] 288740 0
Approval date [1] 288740 0
04/01/2010
Ethics approval number [1] 288740 0
Ethics committee name [2] 288741 0
Institutional Review Board of the University Hospital-Quality control unit of the Faculty of Medicine
Ethics committee address [2] 288741 0
Ethics committee country [2] 288741 0
Egypt
Date submitted for ethics approval [2] 288741 0
Approval date [2] 288741 0
04/01/2010
Ethics approval number [2] 288741 0

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

Contacts
Principal investigator
Name 37598 0
Dr Ahmad Sameer Sanad
Address 37598 0
Minia University, Faculty of Medicine, Department of Obstetrics and Gynecology. Minia-Egypt
Country 37598 0
Egypt
Phone 37598 0
+201000222994
Fax 37598 0
+2-086-2332666
Email 37598 0
[email protected]
Contact person for public queries
Name 37599 0
Ahmad Sameer Sanad
Address 37599 0
Minia University, Faculty of Medicine, Department of Obstetrics and Gynecology. Minia-Egypt
Country 37599 0
Egypt
Phone 37599 0
+201000222994
Fax 37599 0
+2-086-2332666
Email 37599 0
[email protected]
Contact person for scientific queries
Name 37600 0
Ahmad Sameer Sanad
Address 37600 0
Minia University, Faculty of Medicine, Department of Obstetrics and Gynecology. Minia-Egypt
Country 37600 0
Egypt
Phone 37600 0
+201000222994
Fax 37600 0
+2-086-2332666
Email 37600 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
No additional documents have been identified.