Trial Review

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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.
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.
Secondary ID [1] 283049 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometrial polyps in infertility 289886 0
Condition category
Condition code
Reproductive Health and Childbirth 290251 290251 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287767 0
Treatment: Drugs
Comparator / control treatment
microcellulose placebo tablets.
Control group
Placebo

Outcomes
Primary outcome [1] 290269 0
chemical pregnancy rate by serum beta hCG, and clinical pregnancy rate by detecting gestational sac with ultrasound.
Timepoint [1] 290269 0
Beta hCG was assayed 2 days after the date of missed period and ultrasonography was done one week later.
Secondary outcome [1] 304226 0
persistence of polyps as seen by transvaginal sonography.
Timepoint [1] 304226 0
5 days from onset of menstrual bleeding.

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.
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
other causes of infertility, irregular or abnormal menstrual periods

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)
sealed envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated tables
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
9/06/2012
Date of last participant enrolment
Anticipated
1/12/2013
Actual
30/06/2014
Date of last data collection
Anticipated
Actual
10/02/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 5324 0
Egypt
State/province [1] 5324 0
Alexandria

Funding & Sponsors
Funding source category [1] 287813 0
Self funded/Unfunded
Name [1] 287813 0
Country [1] 287813 0
Primary sponsor type
Individual
Name
Mervat sheikhelarab Elsedeek Omran. Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address
649 Elhoreya road Janaklis, Alexandria Egypt.
03312
Country
Egypt
Secondary sponsor category [1] 286542 0
None
Name [1] 286542 0
none
Address [1] 286542 0
Country [1] 286542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289763 0
Alexandria Faculty of Medicine institutional review board
Ethics committee address [1] 289763 0
Alexandria faculty of medicine, Azarita, Alexandria, Egypt.
Post code: 03312
Ethics committee country [1] 289763 0
Egypt
Date submitted for ethics approval [1] 289763 0
Approval date [1] 289763 0
20/05/2012
Ethics approval number [1] 289763 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42290 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 42290 0
649 Elhoreya road, Janaklis, Alexandria.
03312
Country 42290 0
Egypt
Phone 42290 0
+203 5759915
Fax 42290 0
Email 42290 0
mervatsheikhelarab@yahoo.com
Contact person for public queries
Name 42291 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 42291 0
649 Elhoreya road, Janaklis, Alexandria.
03312
Country 42291 0
Egypt
Phone 42291 0
+203 5759915
Fax 42291 0
Email 42291 0
mervatsheikhelarab@yahoo.com
Contact person for scientific queries
Name 42292 0
Prof Mervat Sheikhelarab Elsedeek Omran.Professor of obstetrics and gynecology, Faculty of medicine, alexandria university.
Address 42292 0
649 Elhoreya road, Janaklis, Alexandria.
03312
Country 42292 0
Egypt
Phone 42292 0
+203 5759915
Fax 42292 0
Email 42292 0
mervatsheikhelarab@yahoo.com

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No Supporting Document Provided



Results publications and other study-related documents

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