Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study|
- Number of mature follicles in the study and control group.
- Number of cycles where the rFSH dose is changed.
- Number of cycles cancelled or converted to in vitro fertilisation.
- Pregnancy rate. [ Time Frame: October 2008 ]
|Study Start Date:||September 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Active Comparator: "Individual" or "standard" rFSH dose
Patients were randomized to recieve "individual" (50, 75 or 100 IU/day) or "standard" (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient's body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64).
Drug: rFSH drug dose
"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
Active Comparator: "Standard" rFSH dose
"Standard" dose of rFSH
Drug: "Standard" rFSH dose
"Standard" rFSH dose was 75 IU/day
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374634
|The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet|
|Copenhagen East, Denmark, 2100|
|Study Director:||Anders N Andersen, Professor,MD||The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark|