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

This study has been completed.
Information provided by (Responsible Party):
Nina la Cour Freiesleben, Rigshospitalet, Denmark Identifier:
First received: September 8, 2006
Last updated: September 30, 2011
Last verified: September 2011

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.

Condition Intervention Phase
Drug: rFSH drug dose
Drug: "Standard" rFSH dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Number of mature follicles in the study and control group.

Secondary Outcome Measures:
  • Number of cycles where the rFSH dose is changed.
  • Number of cycles cancelled or converted to in vitro fertilisation.
  • Pregnancy rate. [ Time Frame: October 2008 ]

Enrollment: 234
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: "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).
Drug: rFSH drug dose
"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
Active Comparator: "Standard" rFSH dose
"Standard" dose of rFSH
Drug: "Standard" rFSH dose
"Standard" rFSH dose was 75 IU/day


Ages Eligible for Study:   25 Years to 39 Years
Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its identifier: NCT00374634

The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet
Copenhagen East, Denmark, 2100
Sponsors and Collaborators
Nina la Cour Freiesleben
Study Director: Anders N Andersen, Professor,MD The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nina la Cour Freiesleben, MD PhD, Rigshospitalet, Denmark Identifier: NCT00374634     History of Changes
Other Study ID Numbers: indvFSH2006
Study First Received: September 8, 2006
Last Updated: September 30, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 15, 2014