Home » Trials » SLCTR/2014/009
Clomiphene Citrate vs Letrozole in the treatment of anovulatory infertility
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SLCTR Registration Number
SLCTR/2014/009
Date of Registration
The date of last modification
Apr 30, 2019
Trial Status
Scientific Title of Trial
Clomiphene Citrate vs Letrozole in the treatment of anovulatory infertility
Public Title of Trial
Clomiphene Citrate vs Letrozole in the treatment of anovulatory infertility
Disease or Health Condition(s) Studied
Anovulatory infertility
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1154-3430
Any other number(s) assigned to the trial and issuing authority
P/04/01/2014 (Ethics Review Committee, University of Kelaniya)
What is the research question being addressed?
Clomiphene citrate or letrozole: which ovarian stimulating agent is the best choice of first line treatment?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Patients attending to the subfertility clinic will be recruited. Tubal patency will be diagnosed by doing a hysterosalpingogram or a laparoscopy and chromotubation.
Selected females will be randomized in to two treatment groups Each participant will either receive clomiphene citrate 50 mg daily from the second day to sixth day of the menstrual cycle or letrozole 2.5 mg daily for the same period according to the number allocated by the software(single-blind approach). The person assessing follicular development will also be blind to the allocation.
Inclusion criteria
• Females < 40 years • Infertile ( inability to achieve a pregnancy after a one year of regular unprotected sexual intercourse.) • Anovulatory - diagnosed by assessing mid-luteal progesterone levels and assessment of follicular development by serial trans-vaginal ultrasound scanning • Proven tubal patency
Exclusion criteria
• Females having tubal factor infertility • Females whose partners have male factor subfertility
Primary outcome(s)
|
1.
Follicular development assessed bytrasvaginal ultrasound scan |
[ 12th day of the cycle ] |
Secondary outcome(s)
|
1.
|
[
|
Target number/sample size
96
Countries of recruitment
Sri Lanka
Anticipated start date
2014-05-01
Anticipated end date
2014-11-01
Date of first enrollment
2014-01-05
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-02-12
Approval number
P/04/01/2014
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. M C Gihan
Lecturer in Obstetrics & Gynaecology, Faculty of Medicine, University of Peradeniya and Registrar inObstetrics & Gynaecology
Department of Obstetrics & Gynaecology, Faculty of Medicine, University of Peradeniya.
0773601051
champikagihan@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
