Home » Trials » SLCTR/2008/015
A study on anti-eostrogen clomifene citrate and aromatase inhibitor letrozole in induction of ovulation, in WHO group II anovulatory subjects, and in augmentation of ovulation in ovulatory infertility
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SLCTR Registration Number
SLCTR/2008/015
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
A study on anti-eostrogen clomifene citrate and aromatase inhibitor letrozole in induction of ovulation, in WHO group II anovulatory subjects, and in augmentation of ovulation in ovulatory infertility
Public Title of Trial
The efficacy of letrozole compared to clomifene in induction and augmentation of ovulation in infertility
Disease or Health Condition(s) Studied
Anovulatory and unexplained infertility
Scientific Acronym
None
Public Acronym
None
Brief title
Efficacy of letrozole in ovulation induction
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P10/02/2008 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Whether the aromatase inhibitor letrozole is equal or superior to the commonly used anti-oestrogen clomifene citrate in induction and augmentation of ovulation in infertility?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
In phase one: ovulation induction with clomifene citrate followed by letrozole in patients with anovulatory infertility In phase two: Subjects with unexplained infertility would undergo augmentation of ovulation with either clomifene citrate or letrozole randomly followed by other agent after a three month drug free interval
Inclusion criteria
Phase I: participants with WHO group II anovulatory infertility Phase II: Participants with unexplained infertility
Exclusion criteria
Primary outcome(s)
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1.
Phase 1: Ovulation rate, endometrial characteristics Phase 2: Monofolicle development rate, endometrial characteristics |
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Secondary outcome(s)
|
1.
Follicular phase and luteal phase endocrinological changes |
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Target number/sample size
Phase 1: 100, Phase 2 : 25 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2008-08-15
Anticipated end date
2009-02-15
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2008-03-18
Approval number
P10/02/2008
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 and Gynaecology
Faculty of Medicine, No 6, Thalagolla Road, Ragama
0714 089474
0112958337
palihawadana_t@sltnet.lk
Contact Person for Public Queries
Dr. Thilina S Palihawadana
Lecturer, Department of Obstetrics and Gynaecology
Faculty of Medicine, No 6, Thalagolla Road, Ragama
0714 089474
0112958337
palihawadana_t@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
