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Completed

NCT Number: NCT00374634

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

25 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet

Copenhagen East, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rFSH drug dose

Drug

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

"Standard" rFSH dose

Drug

"Standard" rFSH dose was 75 IU/day

Primary outcomes

  1. Number of mature follicles in the study and control group.

Secondary outcomes

  1. Number of cycles where the rFSH dose is changed.

  2. Number of cycles cancelled or converted to in vitro fertilisation.

  3. Pregnancy rate.

    Time frame: October 2008

Sponsors and collaborators

Lead sponsor

Nina la Cour Freiesleben

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2006
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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