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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina la Cour Freiesleben, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00374634
First received: September 8, 2006
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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
Infertility
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

  Eligibility

Ages Eligible for Study:   25 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374634

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nina la Cour Freiesleben, MD PhD, Rigshospitalet, Denmark
ClinicalTrials.gov 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:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014