Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Number of mature follicles in the study and control group.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 (Drug)
"Standard" rFSH dose
"Standard" dose of rFSH
Intervention: "Standard" rFSH dose (Drug)
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)
Investigators
Nina la Cour Freiesleben
MD PhD
Rigshospitalet, Denmark