Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00374634|
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : October 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: rFSH drug dose Drug: "Standard" rFSH dose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||October 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|