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

NCT ID: NCT00374634

Last Updated: 2011-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"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).

Group Type ACTIVE_COMPARATOR

rFSH drug dose

Intervention Type DRUG

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

"Standard" rFSH dose

"Standard" dose of rFSH

Group Type ACTIVE_COMPARATOR

"Standard" rFSH dose

Intervention Type DRUG

"Standard" rFSH dose was 75 IU/day

Interventions

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rFSH drug dose

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

Intervention Type DRUG

"Standard" rFSH dose

"Standard" rFSH dose was 75 IU/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nina la Cour Freiesleben

OTHER

Sponsor Role lead

Responsible Party

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Nina la Cour Freiesleben

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders N Andersen, Professor,MD

Role: STUDY_DIRECTOR

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

Locations

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

Copenhagen East, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 19602518 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20303323 (View on PubMed)

Other Identifiers

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indvFSH2006

Identifier Type: -

Identifier Source: org_study_id