Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000259246
Ethics application status
Approved
Date submitted
10/12/2017
Date registered
16/02/2018
Date last updated
16/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of progestin induced period on the outcome of clomid ovulation induction in women with polycystic ovary syndrome.
Scientific title
Impact of progestin induced withdrawal bleeding on the outcome of ovulation induction with clomiphene citrate in women with polycystic ovary syndrome.
Secondary ID [1] 293575 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
female infertility 305813 0
Condition category
Condition code
Reproductive Health and Childbirth 305032 305032 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ovulation induction using clomiphene citrates oral tablets in the dose of 100 mg daily for 5 days following induced menstrual period by dydrogesterone oral tablets in the dose of 30 mg for 7 days. Compliance with the intervention was assured by return of empty tablet strips.
Intervention code [1] 299828 0
Treatment: Drugs
Comparator / control treatment
ovulation induction using clomiphene citrates oral tablets in a a dose of 100 mg daily for 5 days without induced menstrual period.
Control group
Active

Outcomes
Primary outcome [1] 304195 0
Clinical pregnancy identified as visualization of gestational sac(s) inside the uterus by transvaginal sonography 4 to 6 weeks after the end of treatment.
Timepoint [1] 304195 0
4 to 6 weeks after end of treatment
Primary outcome [2] 304196 0
Ovulation detection by follicle scanning done by transvaginal sonography..
Timepoint [2] 304196 0
One week after the end of treatment.
Primary outcome [3] 304197 0
Endometrial thickness measured in mm by transvaginal sonography at 18-22mm follicle diameter.
Timepoint [3] 304197 0
One week after end of treatment.
Secondary outcome [1] 341184 0
Ongoing pregnancy detected as fetal cardiac pulsations seen by transvaginal sonography 2 weeks after visualization of gestational sac in pregnannt cases.
Timepoint [1] 341184 0
8 weeks after the end of treatment

Eligibility
Key inclusion criteria
Women with polycystic ovary syndrome
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Other causes of infertility

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)
Closed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
t test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/05/2014
Date of last participant enrolment
Anticipated
Actual
20/05/2017
Date of last data collection
Anticipated
Actual
16/08/2017
Sample size
Target
80
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 9424 0
Egypt
State/province [1] 9424 0
Alexandria

Funding & Sponsors
Funding source category [1] 298189 0
Hospital
Name [1] 298189 0
Shatby maternity university hospital.
Country [1] 298189 0
Egypt
Primary sponsor type
Individual
Name
Mervat Sheikhelarab Elsedeek
Address
649 Elhoreya rd. Gianaklis, Alexandria, Egypt
postal code: 03312
Country
Egypt
Secondary sponsor category [1] 297287 0
None
Name [1] 297287 0
Address [1] 297287 0
Country [1] 297287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299202 0
Research ethics committee of Faculty of Medicine, Alexandria university.
Ethics committee address [1] 299202 0
Faculty of Medicine, Azarita, Alexandria.
Ethics committee country [1] 299202 0
Egypt
Date submitted for ethics approval [1] 299202 0
22/04/2014
Approval date [1] 299202 0
13/05/2014
Ethics approval number [1] 299202 0
168/14

Summary
Brief summary
Women with polycystic ovary syndrome (PCOS) are anovulatory and oligomenorrheic. Clomiphene citrates is the first line drug used to induce ovulation and achieve pregnancy in these women. The study aims to find if induced withdrawal bleeding using progestin has an impact on success of ovulation, endometrium, and pregnancy in these women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54094 0
Prof Mervat Sheikhelarab Elsedeek
Address 54094 0
649 Elhoreya Rd. Alexandria Egypt.
postal code: 003312.
Phone: +203 5759915
Country 54094 0
Egypt
Phone 54094 0
+203 5759915
Fax 54094 0
Email 54094 0
[email protected]
Contact person for public queries
Name 54095 0
Prof Mervat Sheikhelarab Elsedeek
Address 54095 0
649 Elhoreya Rd. Alexandria Egypt.
postal code: 003312.
Phone: +203 5759915
Country 54095 0
Egypt
Phone 54095 0
+203 5759915
Fax 54095 0
Email 54095 0
[email protected]
Contact person for scientific queries
Name 54096 0
Prof Mervat Sheikhelarab Elsedeek
Address 54096 0
649 Elhoreya Rd. Alexandria Egypt.
postal code: 003312.
Country 54096 0
Egypt
Phone 54096 0
+203 5759915
Fax 54096 0
Email 54096 0
[email protected]

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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.