Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

Ovarian Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829075
• Other study ID #: VLC-MM-0501-37
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2009
• Last updated: January 23, 2009
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2009
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Ovarian Stimulation

Intervention

Drug:
• r-FSH

• HP-hMG

• r-FSH plus HP-hMG

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one year	No