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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: rFSH drug dose; Drug: "Standard" rFSH dose

• Registration Number: NCT00374634
• Lead Sponsor: Nina la Cour Freiesleben

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-30
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Individual" or "standard" rFSH dose	rFSH drug 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).
"Standard" rFSH dose	"Standard" rFSH dose	"Standard" dose of rFSH

Primary Outcome Measures

Name	Time	Method
Number of mature follicles in the study and control group.

Secondary Outcome Measures

Name	Time	Method
Number of cycles where the rFSH dose is changed.
Number of cycles cancelled or converted to in vitro fertilisation.
Pregnancy rate.	October 2008

Trial Locations

Locations (1)

The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen East, Denmark