NCT00374634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

September 8, 2006

Last Update Submit

September 30, 2011

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Number of cycles where the rFSH dose is changed.

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

  • Pregnancy rate.

    October 2008

Study Arms (2)

"Individual" or "standard" rFSH dose

ACTIVE COMPARATOR

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

"Standard" rFSH dose

ACTIVE COMPARATOR

"Standard" dose of rFSH

Drug: "Standard" rFSH dose

Interventions

rFSH drug doseDRUG

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

"Individual" or "standard" rFSH dose
"Standard" rFSH doseDRUG

"Standard" rFSH dose was 75 IU/day

"Standard" rFSH dose

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • More than three former stimulated intrauterine insemination cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen East, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 19602518BACKGROUND

  • 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.

    PMID: 20303323DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Anders N Andersen, Professor,MD

    The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

October 3, 2011

Record last verified: 2011-09

Locations

DK(1)