Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001325796
Ethics application status
Approved
Date submitted
28/09/2013
Date registered
2/12/2013
Date last updated
2/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Serum anti-mullarian hormone levels in women with unexplained recurrent pregnancy loss.
Scientific title
comparison between serum antimullarian hormone (AMH) in women with history of unexplained recurrent pregnancy loss and multiparous healthy volunteers with comparable age and body mass index ( BMI)
Secondary ID [1] 283324 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent pregnancy loss 290216 0
Condition category
Condition code
Reproductive Health and Childbirth 290606 290606 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
measurement of serum antimullarian hormone (AMH) by radio immunoassay (RIA) once at time of participant recruitment during early follicular phase of any menstrual cycle in non-pregnant women with history of two or more pregnancy losses before 12 weeks within the last two years.
Intervention code [1] 288046 0
Not applicable
Comparator / control treatment
measurement of AMH in non pregnant healthy multiparous volunteers with comparable age and BMI.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290621 0
serum AMH values by RIA
Timepoint [1] 290621 0
Single measurement at inclusion in study - that is, when participant is recruited into this trial
Secondary outcome [1] 304922 0
nil
Timepoint [1] 304922 0
nil

Eligibility
Key inclusion criteria
cases were non-pregnant women with history of 2 or more successive spontaneous pregnancy losses between 6 weeks and 12 weeks gestational age within the last 2 years, while the key inclusion criteria for control group was giving birth of a full term baby within the last 2 years.
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of a disease or condition that explains the cause of pregnancy loss.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2010
Actual
13/02/2010
Date of last participant enrolment
Anticipated
4/03/2013
Actual
1/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5450 0
Egypt
State/province [1] 5450 0

Funding & Sponsors
Funding source category [1] 288060 0
Self funded/Unfunded
Name [1] 288060 0
Country [1] 288060 0
Primary sponsor type
University
Name
Faculty of Medicine, Alexandria University
Address
Alexandria faculty of medicine, Azarita, Alexandria, Egypt.
postal code: 03312
Country
Egypt
Secondary sponsor category [1] 286782 0
None
Name [1] 286782 0
Address [1] 286782 0
Country [1] 286782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289985 0
Alexandria Faculty of Medicine institutional review board .
Ethics committee address [1] 289985 0
Faculty of Medicine, Alexandria University. Azarita, Aexandria, Egypt. 03312
Ethics committee country [1] 289985 0
Egypt
Date submitted for ethics approval [1] 289985 0
26/07/2009
Approval date [1] 289985 0
05/09/2009
Ethics approval number [1] 289985 0
214/2009

Summary
Brief summary
comparison of serum AMH values in two groups; study group comprising 30 women with recurrent unexplained miscarriages between 6 and 12 weeks, and control group of multiparous women of comparable age, and BMI with recent delivery of a full term baby.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43370 0
Prof Mervat Sheikhelarab Elsedeek Omran.
Address 43370 0
Professor of obstetrics and gynecology, Faculty of medicine, Alexandria university.
649 Elhoreya road, Alexandria, Egypt.
03312
Country 43370 0
Egypt
Phone 43370 0
+203 5759915
Fax 43370 0
Email 43370 0
[email protected]
Contact person for public queries
Name 43371 0
Prof Mervat Sheikhelarab Elsedeek Omran.
Address 43371 0
Professor of obstetrics and gynecology, Faculty of medicine, Alexandria university.649 Elhoreya road, Alexandria, Egypt.
03312
Country 43371 0
Egypt
Phone 43371 0
+203 5759915
Fax 43371 0
Email 43371 0
[email protected]
Contact person for scientific queries
Name 43372 0
Prof Mervat Sheikhelarab Elsedeek Omran.
Address 43372 0
Professor of obstetrics and gynecology, Faculty of medicine, Alexandria university.649 Elhoreya road, Alexandria, Egypt.
03312
Country 43372 0
Egypt
Phone 43372 0
+203 5759915
Fax 43372 0
Email 43372 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
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Documents added automatically
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