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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
rFSH drug dose
"Standard" rFSH dose
Sponsored by
Nina la Cour Freiesleben
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

25 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

"Individual" or "standard" rFSH dose

"Standard" rFSH dose

Arm Description

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).

"Standard" dose of rFSH

Outcomes

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.

Full Information

First Posted
September 8, 2006
Last Updated
September 30, 2011
Sponsor
Nina la Cour Freiesleben
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1. Study Identification

Unique Protocol Identification Number
NCT00374634
Brief Title
Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
Official Title
Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nina la Cour Freiesleben

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Individual" or "standard" rFSH dose
Arm Type
Active Comparator
Arm Description
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).
Arm Title
"Standard" rFSH dose
Arm Type
Active Comparator
Arm Description
"Standard" dose of rFSH
Intervention Type
Drug
Intervention Name(s)
rFSH drug dose
Intervention Description
"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
Intervention Type
Drug
Intervention Name(s)
"Standard" rFSH dose
Intervention Description
"Standard" rFSH dose was 75 IU/day
Primary Outcome Measure Information:
Title
Number of mature follicles in the study and control group.
Secondary Outcome Measure Information:
Title
Number of cycles where the rFSH dose is changed.
Title
Number of cycles cancelled or converted to in vitro fertilisation.
Title
Pregnancy rate.
Time Frame
October 2008

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders N Andersen, Professor,MD
Organizational Affiliation
The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen East
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19602518
Citation
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.
Results Reference
background
PubMed Identifier
20303323
Citation
Freiesleben Nl, Rosendahl M, Johannsen TH, Lossl K, Loft A, Bangsboll S, Friis-Hansen L, Pinborg A, Andersen AN. Prospective investigation of serum anti-Mullerian hormone concentration in ovulatory intrauterine insemination patients: a preliminary study. Reprod Biomed Online. 2010 May;20(5):582-7. doi: 10.1016/j.rbmo.2010.02.007. Epub 2010 Feb 12.
Results Reference
derived

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

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