Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination

Nina la Cour Freiesleben

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: "Standard" rFSH dose; Drug: rFSH drug dose

Study type: Interventional

Funder types: Other

Identifiers

NCT00374634

indvFSH2006

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: Female

Ages: 25 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

"Individual" or "standard" rFSH dose

Active Comparator group

Description:

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).

Treatment:

Drug: rFSH drug dose

"Standard" rFSH dose

Active Comparator group

Description:

"Standard" dose of rFSH

Treatment:

Drug: "Standard" rFSH dose