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Trial registered on ANZCTR
Registration number
ACTRN12613000990729
Ethics application status
Approved
Date submitted
21/08/2013
Date registered
5/09/2013
Date last updated
14/12/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Impact of luteal progesterone therapy on endometrial polyps accidentally discovered during routine infertility evaluation: randomized trial.
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Scientific title
women with detected endometrial polyps during routine infertility evaluation are randomized to receive luteal phase support by oral dydrogesterone or placebo to find out the impact on pregnancy rate and post-menstrual polyp persistence and size.
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Secondary ID [1]
283049
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
endometrial polyps in infertility
289886
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Condition category
Condition code
Reproductive Health and Childbirth
290251
290251
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0
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Fertility including in vitro fertilisation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
luteal phase support by dydrogesterone oral tablets 30 mg/day for 10 days starting 2 days after sonographically detected ovulation. cases were appointed postmenstrually to reevaluate the endometrium and make sure that they received their treatment correctly.
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Intervention code [1]
287767
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Treatment: Drugs
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Comparator / control treatment
microcellulose placebo tablets.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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chemical pregnancy rate by serum beta hCG, and clinical pregnancy rate by detecting gestational sac with ultrasound.
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Assessment method [1]
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Timepoint [1]
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Beta hCG was assayed 2 days after the date of missed period and ultrasonography was done one week later.
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Secondary outcome [1]
304226
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persistence of polyps as seen by transvaginal sonography.
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Assessment method [1]
304226
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Timepoint [1]
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5 days from onset of menstrual bleeding.
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Eligibility
Key inclusion criteria
Presence of endometrial polyp in an asymptomatic regularly menstruating woman ,evaluated for infertility for one year or more, and partner normal semen.
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Minimum age
20
Years
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Maximum age
35
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
other causes of infertility, irregular or abnormal menstrual periods
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelops
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated tables
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample-size was calculated using Chi-square test for independent samples with the occurrence of pregnancy as the primary outcome. For an a-error of 0.05, and a power of 80% the calculated size of each group was 50 cases.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2012
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Actual
9/06/2012
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Date of last participant enrolment
Anticipated
1/12/2013
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Actual
30/06/2014
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Date of last data collection
Anticipated
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Actual
10/02/2016
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment outside Australia
Country [1]
5324
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Egypt
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State/province [1]
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Alexandria
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Funding & Sponsors
Funding source category [1]
287813
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Self funded/Unfunded
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Name [1]
287813
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Address [1]
287813
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Country [1]
287813
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Primary sponsor type
Individual
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Name
Mervat sheikhelarab Elsedeek Omran. Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
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Address
649 Elhoreya road Janaklis, Alexandria Egypt.
03312
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Country
Egypt
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Secondary sponsor category [1]
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None
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Name [1]
286542
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none
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Address [1]
286542
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Country [1]
286542
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289763
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Alexandria Faculty of Medicine institutional review board
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Ethics committee address [1]
289763
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Alexandria faculty of medicine, Azarita, Alexandria, Egypt. Post code: 03312
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Ethics committee country [1]
289763
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Egypt
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Date submitted for ethics approval [1]
289763
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Approval date [1]
289763
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20/05/2012
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Ethics approval number [1]
289763
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Summary
Brief summary
Asymptomatic women with endometrial polyps accidentally discovered during trans-vaginal sonography done for routine infertility evaluation were either given luteal dydrogesterone for endometrial support or placebo and followed up for occurrence of pregnancy and persistence of polyp after period if no pregnancy occurred.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
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Address
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649 Elhoreya road, Janaklis, Alexandria. 03312
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Country
42290
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Egypt
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Phone
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+203 5759915
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Fax
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Email
42290
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[email protected]
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Contact person for public queries
Name
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Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
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Address
42291
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649 Elhoreya road, Janaklis, Alexandria. 03312
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Country
42291
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Egypt
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Phone
42291
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+203 5759915
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Fax
42291
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Email
42291
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[email protected]
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Contact person for scientific queries
Name
42292
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Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
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Address
42292
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649 Elhoreya road, Janaklis, Alexandria. 03312
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Country
42292
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Egypt
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Phone
42292
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+203 5759915
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Fax
42292
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Email
42292
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[email protected]
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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.
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