Home » Trials » SLCTR/2009/010
A prospective randomized comparison between low dose step-up and step-down gonadotrophin regimes in controlled ovarian stimulation
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SLCTR Registration Number
SLCTR/2009/010
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A prospective randomized comparison between low dose step-up and step-down gonadotrophin regimes in controlled ovarian stimulation
Public Title of Trial
A comparison of low dose step-up and step-down FSH regimes in treatment of infertility due to anovulation
Disease or Health Condition(s) Studied
Anovulatory infertility
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Which of the two FSH regimes are prefered in treatment of anovulatory infertility in terms of efficacy, side efefcts and the cost of treatment. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
One study arm would recieve FSH in a low dose step-up regime while the other will recieve a low dose step-down regime.
Inclusion criteria
Subjects with WHO group II anovulation who are having either clomifene resistance or clomifene failure.
Exclusion criteria
Previous ovarian surgery or any endocrinopathy other than polycystic ovarian syndrome.
Primary outcome(s)
|
1.
Ovulation rate, incidence of ovarian hyperstimulation syndorme, total FSH drug requirement. |
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Secondary outcome(s)
|
1.
Mono follicle development rate, endometrial thickness, Serum oestradiol levels with mature follicle, cycle cancellation rate |
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Target number/sample size
Twenty five treatment cycles in each study arm.
Countries of recruitment
Sri Lanka
Anticipated start date
2009-08-01
Anticipated end date
2010-01-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
National Science Foundation
Regulatory approvals
Status
Approved
Date of Approval
2005-12-12
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Thilina S Palihawadana
Lecturer, Department of Obstetrics & Gynaecology
Faculty of Medicine, P O Box 6, Thalagolla Road, Ragama
0714089474
palihawadana_t@sltnet.lk
Contact Person for Public Queries
Dr. Thilina S Palihawadana
Lecturer, Department of Obstetrics & Gynaecology
Faculty of Medicine, P O Box 6, Thalagolla Road, Ragama
0714089474
palihawadana_t@sltnet.lk
Primary study sponsor/organization
National Science Foundation
380/71, Bauddhaloka Mawatha, Colombo 07
112697538
112697166
nrc@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
