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

Infertility Clinical Trial

Official title:

Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374634
• Other study ID #: indvFSH2006
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: September 30, 2011
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: September 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 39 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• rFSH drug dose
"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
• "Standard" rFSH dose
"Standard" rFSH dose was 75 IU/day

Locations

Country	Name	City	State
Denmark	The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet	Copenhagen East

Sponsors (1)

Lead Sponsor	Collaborator
Nina la Cour Freiesleben

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

la Cour Freiesleben N, Lossl K, Bogstad J, Bredkjaer HE, Toft B, Rosendahl M, Loft A, Bangsboll S, Pinborg A, Nyboe Andersen A. Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study. Hum Reprod. 2009 Oct;24(10):2523-30. doi: 10.1093/humrep/dep239. Epub 2009 Jul 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mature follicles in the study and control group.
Secondary	Number of cycles where the rFSH dose is changed.
Secondary	Number of cycles cancelled or converted to in vitro fertilisation.
Secondary	Pregnancy rate.		October 2008