Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

Phase 4

Completed

• Conditions: Ovarian Stimulation
• Interventions: Drug: r-FSH; Drug: HP-hMG; Drug: r-FSH plus HP-hMG

• Registration Number: NCT00829075
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study Completion: 2006-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Last Update Submitted: 2009-01-23
• Study First Posted: 2009-01-26
• Last Update Posted: 2009-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
I	r-FSH	only r-FSH TREATMENT
II	HP-hMG	only HP-hMG TREATMENT
III	r-FSH plus HP-hMG	r-FSH plus HP-hMG TREATMENT

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain