A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome

Instituto Valenciano de Infertilidad, IVI VALENCIA1 site in 1 countryJanuary 2005

ConditionsOvarian Stimulation

Interventionsr-FSH HP-hMG r-FSH plus HP-hMG

Drugsr-FSH HP-hMG r-FSH plus HP-hMG

Overview

Phase: Phase 4
Intervention: r-FSH
Conditions: Ovarian Stimulation
Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Locations: 1
Primary Endpoint: The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

December 2006

Last Updated

17 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Eligibility Criteria

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

Arms & Interventions

I

only r-FSH TREATMENT

Intervention: r-FSH

II

only HP-hMG TREATMENT

Intervention: HP-hMG

III

r-FSH plus HP-hMG TREATMENT

Intervention: r-FSH plus HP-hMG

Outcomes

Primary Outcomes

The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program.

Time Frame: one year