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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00374634
Enrollment
234
Registered
2006-09-11
Start date
2006-09-30
Completion date
2008-10-31
Last updated
2011-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

DRUGrFSH drug dose

Individual rFSH dose (50, 75 or 100 IU rFSH/day)

DRUGStandard rFSH dose

Standard rFSH dose was 75 IU/day

Sponsors

Nina la Cour Freiesleben
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 39 Years
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

Design outcomes

Primary

MeasureTime frame
Number of mature follicles in the study and control group.

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026