Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

NCT ID: NCT00829075

Last Updated: 2009-01-26

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

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.

Detailed Description

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Conditions

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Ovarian Stimulation

Study Groups

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I

only r-FSH TREATMENT

Group Type EXPERIMENTAL

r-FSH

Intervention Type DRUG

II

only HP-hMG TREATMENT

Group Type EXPERIMENTAL

HP-hMG

Intervention Type DRUG

III

r-FSH plus HP-hMG TREATMENT

Group Type EXPERIMENTAL

r-FSH plus HP-hMG

Intervention Type DRUG

Interventions

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r-FSH

Intervention Type DRUG

HP-hMG

Intervention Type DRUG

r-FSH plus HP-hMG

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy women 18-34 years of age
* regular menstrual cycles
* no family history of hereditary or chromosomal diseases
* normal karyotype
* BMI 18-29 Kg/m2
* negative screening for sexually transmitted diseases

Exclusion Criteria

* women with PCOS were not included in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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IVI Valencia

Principal Investigators

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Marco Melo, MDPhD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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IVI Valencia

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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VLC-MM-0501-37

Identifier Type: -

Identifier Source: org_study_id

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