Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
Overview
- Phase
- Phase 4
- Intervention
- rFSH drug dose
- Conditions
- Infertility
- Sponsor
- Nina la Cour Freiesleben
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Number of mature follicles in the study and control group.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Nina la Cour Freiesleben
MD PhD
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Age between 25-39 years
- •First stimulation with rFSH only
- •Indication for intrauterine insemination with standard rFSH starting dose
- •Regular menstrual bleeding with a cycle between 21-35 days
- •Two ovaries
- •Bilateral tuba patency
- •Semen analysis must be sufficient for insemination according to the diagnostic analysis.
Exclusion Criteria
- •More than three former stimulated intrauterine insemination cycles
Arms & Interventions
"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).
Intervention: rFSH drug dose
"Standard" rFSH dose
"Standard" dose of rFSH
Intervention: "Standard" rFSH dose
Outcomes
Primary Outcomes
Number of mature follicles in the study and control group.
Secondary Outcomes
- Number of cycles where the rFSH dose is changed.
- Number of cycles cancelled or converted to in vitro fertilisation.
- Pregnancy rate.(October 2008)