| 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 (in lay language) | A comparison of low dose step-up and step-down FSH regimes in treatment of infertility due to anovulation | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Anovulatory infertility | |
| 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. ? | |
| Study design | A propective randomized clinical trial with two study arms. | |
| 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. | |
| Target number / sample size | Twenty five treatment cycles in each study arm. | |
| Primary outcome(s) | Ovulation rate, incidence of ovarian hyperstimulation syndorme, total FSH drug requirement. | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | Mono follicle development rate, endometrial thickness, Serum oestradiol levels with mature follicle, cycle cancellation rate | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/08/2009 | |
| Anticipated end date | 31/01/2010 | |
| Recruitment status | Recruiting | |
| State of ethics review approval | Aproved by the ERC of Faculty of Medicine, Ragama | |
| Funding source(s) | National Science Foundation | |
| Applicant's Email | palihawadana_t@sltnet.lk | |
| Approval Status | Approved | |
| 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 |
|
| Primary Study Sponsor/ Organization | National Science Foundation
380/71, Bauddhaloka mawatha, Colombo 07 112697538 112697166 nrc@sltnet.lk |
|
| Contact Person for Public Queries | Dr. Thilina S Palihawadana Lecturer, Dept of Obstetrics & Gynaecology Faculty of Medicine, P O Box 6, Thalagolla Road, Ragama 0714089474 palihawadana_t@sltnet.lk |
|
| Secondary Study Sponsor(s), (if any) | None |
|
